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  1. StudyEvent: 8214: Registration Information Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
TreatingInstitutionTextCode
Item
Institution CTEP ID
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25705 (NCI Thesaurus ObjectClass)
C1522326 (UMLS 2011AA ObjectClass)
C19992 (NCI Thesaurus ObjectClass-2)
C1516607 (UMLS 2011AA ObjectClass-2)
CL281747 (NCI Metathesaurus Property)
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Protocol ID ACOSOG
Item
Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1515944 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C19712 (NCI Thesaurus Property-2)
Protocol Title
Item
Protocol Title
text
C25191 (NCI Thesaurus ValueDomain)
C2986303 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C42774 (NCI Thesaurus Property)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
TreatingPhysicianOrParticipatingInvestigatorName
Item
Treating Investigator
text
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C37998 (NCI Thesaurus ObjectClass-2)
C1518602 (UMLS 2011AA ObjectClass-2)
C51883 (NCI Thesaurus ObjectClass-3)
C1710470 (UMLS 2011AA ObjectClass-3)
C25936 (NCI Thesaurus ObjectClass-4)
C0035173 (UMLS 2011AA ObjectClass-4)
C25191 (NCI Thesaurus Property)
C1547383 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
OrganizationName
Item
Credited Group or Organization
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C19711 (NCI Thesaurus ObjectClass)
C1522486 (UMLS 2011AA ObjectClass)
C42614 (NCI Thesaurus Property)
C0027365 (UMLS 2011AA Property)
InvestigatorName
Item
Investigator (Credit - Note: The Credit Investigator must be affiliated with the credited Group or Organization and will be accountable for the patient and the site¿s responsibilities during Audit.)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
Research Comments
Item
Comments (Enter case notes optional)
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
Demography Section
PersonBirthDate
Item
Date of Birth
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)
Item
Gender of a Person
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C17357 (NCI Thesaurus Property)
C0079399 (UMLS 2011AA Property)
Code List
Gender of a Person
CL Item
Female Gender (Female)
C46110 (NCI Thesaurus)
C0086287 (UMLS 2011AA)
CL Item
Male Gender (Male)
C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Ethnicity
text
C25372 (NCI Thesaurus Property)
C0683312 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16564 (NCI Thesaurus ObjectClass)
C0015031 (UMLS 2011AA ObjectClass)
Code List
Ethnicity
CL Item
A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (Hispanic or Latino)
C17459 (NCI Thesaurus)
C0086409 (UMLS 2011AA)
CL Item
A Person Not Meeting The Definition For Hispanic Or Latino. (Not Hispanic or Latino)
C41222 (NCI Thesaurus)
C1518424 (UMLS 2011AA)
CL Item
Not Provided Or Available (Not reported)
C43234 (NCI Thesaurus)
C1706613 (UMLS 2011AA)
PersonAddressCountryName
Item
Country of Residence
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25464 (NCI Thesaurus ValueDomain)
C0454664 (UMLS 2011AA ValueDomain)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain-2)
C0027365 (UMLS 2011AA ValueDomain-2)
PersonAddressPostalCode
Item
Zip code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
Item
Race
text
C25372 (NCI Thesaurus Property)
C0683312 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C17049 (NCI Thesaurus ObjectClass)
C0034510 (UMLS 2011AA ObjectClass)
Code List
Race
CL Item
A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska Native)
C41259 (NCI Thesaurus)
C1515945 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)
C41260 (NCI Thesaurus)
C0078988 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)
C16352 (NCI Thesaurus)
C0085756 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)
C41219 (NCI Thesaurus)
C1513907 (UMLS 2011AA)
CL Item
Not Provided Or Available (Not Reported)
C43234 (NCI Thesaurus)
C1706613 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa. (White)
C41261 (NCI Thesaurus)
C0007457 (UMLS 2011AA)
Item
Method of Payment
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)
Code List
Method of Payment
CL Item
Medicaid (Medicaid)
C0025071 (NCI Metathesaurus)
CL Item
Medicaid And Medicare (Medicaid and Medicare)
CL Item
Medicare (Medicare)
C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)
CL Item
Medicare And Private Insurance (Medicare and Private Insurance)
CL Item
Military Or Veterans Sponsored Nos (Military or Veterans Sponsored, Not Otherwise Specified (NOS))
CL Item
Military Sponsored (including Champus & Tricare) (Military Sponsored (including CHAMPUS & TRICARE))
CL Item
No Means Of Payment (no Insurance) (No means of payment (no insurance))
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Private Insurance (Private Insurance)
CL Item
Self Pay (no Insurance) (Self Pay (No Insurance))
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Veterans Sponsored (Veterans Sponsored)
Item Group
General Information
PatientIdentifier
Item
Pt ID#
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25364 (NCI Thesaurus ValueDomain)
C0600091 (UMLS 2011AA ValueDomain)
Patient Initials Last
Item
Last
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1517741 (UMLS CUI-2)
C25536 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
Patient Initials First
Item
First
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C0205435 (UMLS CUI-2)
C25536 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
PatientMiddleInitialsName
Item
Middle
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
C25569 (NCI Thesaurus Property-2)
C0444598 (UMLS 2011AA Property-2)
ContactPersonE-mailText
Item
Email
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25170 (NCI Thesaurus Property)
C0013849 (UMLS 2011AA Property)
C25461 (NCI Thesaurus ObjectClass-2)
C0337611 (UMLS 2011AA ObjectClass-2)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
HealthInsurancePortabilityandAccountabilityActAuthorizationIndicator
Item
Was HIPAA Authorization included in Study Informed Consent
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C62504 (NCI Thesaurus ObjectClass)
C0600593 (UMLS 2011AA ObjectClass)
C41192 (NCI Thesaurus Property)
C1524004 (UMLS 2011AA Property)
PatientSignedDischargeMedicalRecordDate
Item
HIPAA Authorization Date
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C0012621 (NCI Metathesaurus Property)
C45258 (NCI Thesaurus Property-2)
C0025102 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Eligibility Checklist
Item
Mode of presentation of peritoneal surface dissemination of colon adenocarcinoma
text
C4349 (NCI Thesaurus ObjectClass)
C0338106 (UMLS 2011AA ObjectClass)
C25313 (NCI Thesaurus Property)
C0442034 (UMLS 2011AA Property)
C25245 (NCI Thesaurus Property-2)
C0205148 (UMLS 2011AA Property-2)
C28222 (NCI Thesaurus Property-3)
C0205221 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Mode of presentation of peritoneal surface dissemination of colon adenocarcinoma
CL Item
Synchronous (Synchronous)
CL Item
Metachronous (Metachronous)
Item
ECOG Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
Code List
ECOG Performance Status
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
Item
Ability to measure peritoneal surface disease
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3367 (NCI Thesaurus Property)
C0037088 (UMLS 2011AA Property)
C3322 (NCI Thesaurus ObjectClass)
C0031149 (UMLS 2011AA ObjectClass)
Code List
Ability to measure peritoneal surface disease
CL Item
Measurable: Peritoneal Surface Disease Apparent On Cross Sectional Imaging (Measurable: peritoneal surface disease apparent on cross sectional imaging)
CL Item
Non-measurable: Peritoneal Surface Disease Unapparent On Cross Sectional Imaging (Non-measurable: peritoneal surface disease unapparent on cross sectional imaging)
Item
Planned chemotherapy
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus ObjectClass-2)
C0392920 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Code List
Planned chemotherapy
CL Item
Oxaliplatin Based Therapy (Oxaliplatin based therapy)
CL Item
Irinotecan-based Therapy (Irinotecan-based therapy)
CL Item
5-fu/lv-capecitabine Alone (5-FU/LV-capecitabine alone)
Item
Planned biologic therapy
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25619 (NCI Thesaurus Property)
C1301732 (UMLS 2011AA Property)
C15187 (NCI Thesaurus ObjectClass)
C0005527 (UMLS 2011AA ObjectClass)
Code List
Planned biologic therapy
CL Item
Bevacizumab (Bevacizumab)
C2039 (NCI Thesaurus)
C0796392 (UMLS 2011AA)
CL Item
Cetuximab (Cetuximab)
C1723 (NCI Thesaurus)
C0879636 (UMLS 2011AA)
CL Item
No Biologic Therapy (No biologic therapy)
Item
Prior first-line therapy for advanced disease
text
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C45792 (NCI Thesaurus Property-2)
C1708063 (UMLS 2011AA Property-2)
C25689 (NCI Thesaurus Property-3)
C1514983 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Prior first-line therapy for advanced disease
CL Item
Chemo Naive (Chemo Naive)
CL Item
Prior First-line Therapy (Prior First-Line Therapy)
Item Group
Eligibility Criteria
PatientAgeInd-2
Item
Age >= 18 years
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
PatientConsentAbilityInd-2
Item
Capable of providing informed consent
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C78209 (NCI Thesaurus Property-2)
C0085732 (UMLS 2011AA Property-2)
ColonAdenocarcinomaPeritonealSurfaceDisseminateInd-2
Item
The patient must have newly diagnosed, previously untreated, histopathologically or cytologically confirmed colon (not appendiceal or rectal) adenocarcinoma (not signet ring cell type) with synchronous or metachronous document limited peritoneal disease dissemination
boolean
C4349 (NCI Thesaurus ObjectClass)
C0338106 (UMLS 2011AA ObjectClass)
C25313 (NCI Thesaurus Property)
C0442034 (UMLS 2011AA Property)
C25245 (NCI Thesaurus Property-2)
C0205148 (UMLS 2011AA Property-2)
C28222 (NCI Thesaurus Property-3)
C0205221 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PeritonealCarcinomatosisTotalInvolvementInd-2
Item
Peritoneal Cancer Index (PCI) of 20 or less determined by helical CT scan +/- staging laparoscopy
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C25313 (NCI Thesaurus ObjectClass)
C0442034 (UMLS 2011AA ObjectClass)
C3693 (NCI Thesaurus ObjectClass-2)
C0205699 (UMLS 2011AA ObjectClass-2)
PeritonealCarcinomatosisInvolvementScore
Item
PCI score
float
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C25313 (NCI Thesaurus ObjectClass)
C0442034 (UMLS 2011AA ObjectClass)
C3693 (NCI Thesaurus ObjectClass-2)
C0205699 (UMLS 2011AA ObjectClass-2)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
HepaticParenchymaMetastasisNegationPresentEligibilityInd-2
Item
No parenchymal hepatic metastases
boolean
C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C19151 (NCI Thesaurus ObjectClass-2)
C0027627 (UMLS 2011AA ObjectClass-2)
C74601 (NCI Thesaurus ObjectClass-3)
C0933845 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25594 (NCI Thesaurus Property-2)
C1518422 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
BileDuctObstructionNoFindingInd-2
Item
No evidence of clinical (jaundice), biochemical (abnormally elevated serum bilirubin and/or alkaline phosphatase) or radiological (ultrasound, CT, or MR) biliary obstruction
boolean
C12376 (NCI Thesaurus ObjectClass)
C0005400 (UMLS 2011AA ObjectClass)
C3284 (NCI Thesaurus ObjectClass-2)
C0028778 (UMLS 2011AA ObjectClass-2)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C3367 (NCI Thesaurus Property-2)
C0037088 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
MalignantPeritonealAscitesNoFindingInd-2
Item
No evidence of symptomatic malignant ascites requiring palliative paracentesis
boolean
C2885 (NCI Thesaurus ObjectClass)
C0003962 (UMLS 2011AA ObjectClass)
C14143 (NCI Thesaurus ObjectClass-2)
C0205282 (UMLS 2011AA ObjectClass-2)
C25313 (NCI Thesaurus ObjectClass-3)
C0442034 (UMLS 2011AA ObjectClass-3)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C3367 (NCI Thesaurus Property-2)
C0037088 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
SmallIntestineLiverDiseaseorDisorderSmallVolumeInd-2
Item
Small volume of disease in the gastro-hepatic ligament defined by a <5 cm mass in the epigastric region on cross-sectional imaging
boolean
C12392 (NCI Thesaurus ObjectClass)
C0023884 (UMLS 2011AA ObjectClass)
C12386 (NCI Thesaurus ObjectClass-2)
C0021852 (UMLS 2011AA ObjectClass-2)
C2991 (NCI Thesaurus ObjectClass-3)
C0012634 (UMLS 2011AA ObjectClass-3)
C25335 (NCI Thesaurus Property)
C0449468 (UMLS 2011AA Property)
C25376 (NCI Thesaurus Property-2)
C0700321 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
SmallBowelNoObstructionInd-2
Item
No cross sectional imaging findings indicative of multi-segmental (>1 site) small bowel obstruction, or small bowel loops matted together, or gross disease of the small bowel mesentery characterized by distortion, thickening or loss of mesenteric vascular clarity
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C12386 (NCI Thesaurus ObjectClass)
C0021852 (UMLS 2011AA ObjectClass)
C3284 (NCI Thesaurus Property-2)
C0028778 (UMLS 2011AA Property-2)
HematogenousDistantNodalMetastasisNoFindingInd-2
Item
No clinical or radiological evidence of hematogenous or distant nodal (retroperitoneal, pelvic, mediastinal, peri-portal or peri-aortic) metastasis
boolean
C25321 (NCI Thesaurus ObjectClass)
C0443203 (UMLS 2011AA ObjectClass)
C19151 (NCI Thesaurus ObjectClass-2)
C0027627 (UMLS 2011AA ObjectClass-2)
C14152 (NCI Thesaurus ObjectClass-3)
C1512376 (UMLS 2011AA ObjectClass-3)
C25323 (NCI Thesaurus ObjectClass-4)
C0443268 (UMLS 2011AA ObjectClass-4)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C3367 (NCI Thesaurus Property-2)
C0037088 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2
Item
ECOG (Zubrod) performance status of 1 or less (Zubrod)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25491 (NCI Thesaurus ObjectClass)
C1512162 (UMLS 2011AA ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)
HematologyAssessmentInd-2
Item
Absolute neutrophil count (ANC) >1200/mm3, white blood cell count (WBC) >4000/mm3 and platelet count >150,000/mm3
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C16673 (NCI Thesaurus ObjectClass)
C0018943 (UMLS 2011AA ObjectClass)
Neutrophil count
Item
ANC
float
C25294 (NCI Thesaurus ObjectClass)
C0200633 (UMLS CUI-1)
C12533 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25304 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Leukocytes (WBC)
Item
WBC
float
C25294 (NCI Thesaurus ObjectClass)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Platelets
Item
Platelet count
float
C25294 (NCI Thesaurus ObjectClass)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureInternationalNormalizedRatioEligibilityDeterminationInd-2
Item
An international normalized ratio (INR) <= 1.5 (patients who are therapeutically anti-coagulated for unrelated medical conditions such as atrial fibrillation and whose anti-thrombotic treatment can be withheld for operation will be eligible)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25352 (NCI Thesaurus Property)
C0525032 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
INR
Item
INR
float
C20200 (NCI Thesaurus Property)
C0525032 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25352 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
PatientPriorRegistrationLaboratoryProcedureEligibilityDeterminationInd-2
Item
Adequate hepatic function must be met as evidenced by total serum bilirubin <= 1.5 mg/dL (patients with total bilirubin >1.5 mg/dL eligible only with Gilbert's syndrome); alkaline phosphatase <2.5 times the upper limit of normal; and/or, SGOT (AST) <1.5 times upper limit of normal [alkaline phosphatase and SGOT (AST) cannot both exceed the upper limit of normal]
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus Property-3)
C0022885 (UMLS 2011AA Property-3)
C25171 (NCI Thesaurus Property-4)
C0013893 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientElevatedBilirubinPersonalMedicalHistoryInd-2
Item
Is total bilirubin >1.5 mg/dL due to Gilbert's syndrome?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C27088 (NCI Thesaurus Property)
C0311468 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
LaboratoryProcedureTotalBilirubinResultSpecifiedValue
Item
Total Bilirubin
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property-2)
C0201913 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C0205369 (UMLS 2011AA ValueDomain-2)
Item
Alkaline phosphatase and AST cannot both exceed the upper limit of normal; select the test that does not exceed the upper limit of normal (check one)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C47891 (NCI Thesaurus Property)
C0039593 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
Code List
Alkaline phosphatase and AST cannot both exceed the upper limit of normal; select the test that does not exceed the upper limit of normal (check one)
CL Item
Alkaline Phosphatase (Alkaline Phosphatase)
CL Item
Sgot (ast) (SGOT (AST))
C25202 (NCI Thesaurus)
C0242192 (UMLS 2011AA)
CL Item
Both Alkaline Phosphatase And Sgot (ast) (Both Alkaline Phosphatase and SGOT (AST))
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C20200 (NCI Thesaurus Property)
C0201850 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C16276 (NCI Thesaurus Property-2)
Alkaline Phosphatase ULN
Item
Alkaline Phosphatase ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0151420 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C16276 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
SGOT (AST)
Item
SGOT (AST)
float
C25294 (NCI Thesaurus ObjectClass)
C0201899 (UMLS CUI-1)
C25202 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue
Item
SGOT (AST) ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
PatientRenalFunctionRequiredInd-2
Item
Serum renal functional parameters, BUN and creatinine are within normal limits
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25518 (NCI Thesaurus Property)
C0542341 (UMLS 2011AA Property)
Blood Urea Nitrogen
Item
BUN
float
C20200 (NCI Thesaurus Property)
C0005845 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C61019 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
LaboratoryProcedureBloodUreaNitrogenResultLowerLimitofNormalValue
Item
BUN LNL
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C61019 (NCI Thesaurus Property-2)
C0005845 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
LaboratoryProcedureBloodUreaNitrogenResultUpperLimitNormalValue
Item
BUN ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C61019 (NCI Thesaurus Property-2)
C0005845 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
Creatinine, Serum
Item
Creatinine
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
LaboratoryProcedureCreatinineResultUnspecifiedLowerLimitofNormalValue
Item
Creatinine LLN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property-2)
C0010294 (UMLS 2011AA Property-2)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
C25555 (NCI Thesaurus ValueDomain-3)
C1518030 (UMLS 2011AA ValueDomain-3)
Creatinine, serum ULN
Item
Creatinine ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
PatientCerebrovascularAccidentMyocardialInfarctionPersonalMedicalHistoryInd-2
Item
Satisfactory cardiopulmonary function (no history of severe congestive heart failure or severe pulmonary disease, as indicated by clinically acceptable risks to undergo major abdominal-cytoreductive surgery).
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C27996 (NCI Thesaurus Property)
C0027051 (UMLS 2011AA Property)
C3390 (NCI Thesaurus Property-2)
C0038454 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientCerebrovascularAccidentMyocardialInfarctionPersonalMedicalHistoryInd-3
Item
No clinical history of acute myocardial infarction within six months of registration Patients who are status post revascularization procedures with satisfactory cardiac function are eligible
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C27996 (NCI Thesaurus Property)
C0027051 (UMLS 2011AA Property)
C3390 (NCI Thesaurus Property-2)
C0038454 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PatientConcurrentSystemicDiseaseorDisorderExclusionCriteriaInd-2
Item
No significant history of a medical problem or co-morbidity that would preclude the patient from undergoing a major abdominal operation such as a history of severe congestive heart failure or active ischemic heart disease
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C13310 (NCI Thesaurus Property)
C0205373 (UMLS 2011AA Property)
C2991 (NCI Thesaurus Property-2)
C0012634 (UMLS 2011AA Property-2)
C25456 (NCI Thesaurus Property-3)
C0205420 (UMLS 2011AA Property-3)
C25370 (NCI Thesaurus Property-4)
C0680251 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PreviousCancerIdentifiedInd-2
Item
No concurrent second malignancy requiring systemic therapy
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25737 (NCI Thesaurus Property)
C0205396 (UMLS 2011AA Property)
Item
Non-pregnant and non-lactating. Women of reproductive age must be willing to use contraception during study therapy. If not a woman of reproductive age (or male) (check NA)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)
Code List
Non-pregnant and non-lactating. Women of reproductive age must be willing to use contraception during study therapy. If not a woman of reproductive age (or male) (check NA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
N/a (N/A)
PsychiatricDiseaseHistoryInd-2
Item
No psychiatric or addictive disorders or other conditions that would preclude the patient from meeting the study requirements
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C2893 (NCI Thesaurus Property)
C0004936 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
ColonAdenocarcinomaNoPriorSecondLineTreatmentInd-2
Item
No prior second-line systemic treatment for metastatic colon adenocarcinoma. Patients who received prior adjuvant therapy for colon adenocarcinoma and/or prior first-line systemic therapy for metastatic colon adenocarcinoma are eligible
boolean
C4349 (NCI Thesaurus ObjectClass)
C0338106 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C54350 (NCI Thesaurus Property-3)
C1710038 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Instructions
PatientQualityofLifeConsentInd-2
Item
Patient has given permission to complete the Quality of Life questionnaires at the time points indicated
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C17047 (NCI Thesaurus Property)
C0518214 (UMLS 2011AA Property)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property-2)
PatientTissueBankingConsentInd-2
Item
Your tissue, from surgery and intra-peritoneal chemotherapy (HIPEC), may be collected and used for the research study
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C0087095 (NCI Metathesaurus Property)
PatientBloodSpecimenConsentInd-2
Item
Your blood may be collected and used for the research study
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-2)
C0370003 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3
Item
Your tissue samples may be kept by the USMCI Biospecimen Network for use in future research to learn about, prevent, detect, treat cancer
boolean
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property-2)
C0439849 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
TissueSpecimenResearchConsentUnrelatedInd-3
Item
Your tissue samples may be used for research about other diseases
boolean
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25328 (NCI Thesaurus ValueDomain-2)
C0445356 (UMLS 2011AA ValueDomain-2)
BloodSpecimenMalignantNeoplasmRelatedResearchConsentInd-3
Item
Your blood samples may be kept by the USMCI Biospecimen Network for use in future research to learn about, prevent, detect, treat cancer
boolean
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property-2)
C0439849 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
BloodSpecimenOtherDiseasesandDisordersResearchConsentInd-3
Item
Your blood samples may be used for research about other diseases
boolean
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C15319 (NCI Thesaurus Property-2)
C2991 (NCI Thesaurus Property-3)
C0012634 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Permission to contact Patient
Item
Your study doctor (or someone he or she chooses) may contact you in the future to ask you to take part in more research
boolean
C16960 (NCI Thesaurus ObjectClass)
C1522577 (UMLS CUI-1)
C67527 (NCI Thesaurus Property)
C0521104 (UMLS CUI-2)
C25460 (NCI Thesaurus Property-2)
C16452 (NCI Thesaurus Property-3)
C38148 (NCI Thesaurus ValueDomain)
Item Group
Randomization
Item
Randomization
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C19712 (NCI Thesaurus ObjectClass)
C1515944 (UMLS 2011AA ObjectClass)
C15538 (NCI Thesaurus ObjectClass-2)
C1522541 (UMLS 2011AA ObjectClass-2)
Code List
Randomization
CL Item
Systemic Therapy (Systemic Therapy)
C15698 (NCI Thesaurus)
C1515119 (UMLS 2011AA)
CL Item
Crs/hipec & System Therapy (CRS/HIPEC & System Therapy)

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