ID

43072

Beschreibung

Southwest Oncology Group Registration Form (S0421) NCT00134056 Docetaxel and Prednisone With or Without Atrasentan in Treating Patients With Stage IV Prostate Cancer and Bone Metastases That Did Not Respond to Previous Hormone Therapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F15A11DF-588A-2157-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F15A11DF-588A-2157-E034-0003BA3F9857

Stichworte

Klinische Studie [Dokumenttyp]

Bone metastasis

Registration

Prostatatumoren

Hochgeladen am

20. September 2021

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0 Legacy

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Southwest Oncology Group Registration Form (S0421) NCT00134056

Modell
Details

No Instruction available.

1 Formulare

StudyEvent: Southwest Oncology Group Registration Form (S0421)
1. No Instruction available.

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Header

Item Group

Header

Protocol ID SWOG

Item

SWOG Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)

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)

Protocol Treatment Arm

Item

Assigned Treatment Arm

text

C25337 (NCI Thesaurus ValueDomain)
C1522541 (UMLS CUI-1)
C32141 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)

ClinicalStudyProtocolAmendmentActivationDate

Item

Activation Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C64382 (NCI Thesaurus Property)
C1879547 (UMLS 2011AA Property)
C41200 (NCI Thesaurus Property-2)
C0680532 (UMLS 2011AA Property-2)

RegistrarSouthwestOncologyGroupIdentifierNumber

Item

Caller's SWOG Roster ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property-2)
C1519429 (UMLS 2011AA Property-2)
C25357 (NCI Thesaurus ObjectClass)
C0557514 (UMLS 2011AA ObjectClass)

Amendment date

Item

Last Amended Date

date

C19464 (NCI Thesaurus ObjectClass)
C0680532 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

Patient demographics

Item Group

Patient demographics

Patient Name

Item

Patient's Name

text

C25191 (NCI Thesaurus ValueDomain)
C1299487 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)

Trial subject ID SWOG

Item

SWOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)

OtherGroupPatientIdentifierNumber

Item

Other Group Patient Number

text

C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C16960 (NCI Thesaurus ObjectClass-2)
C0030705 (UMLS 2011AA ObjectClass-2)
C43359 (NCI Thesaurus ObjectClass-3)
C0441833 (UMLS 2011AA ObjectClass-3)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

Study Number Participating Group

Item

Participating Group/Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Patient Birth Date

Item

Patient's Date of Birth

date

C25164 (NCI Thesaurus ValueDomain)
C0421451 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25155 (NCI Thesaurus Property)

Gender

Item

Patient Gender

text

C25372 (NCI Thesaurus ValueDomain)
C0079399 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17357 (NCI Thesaurus Property)

CL.5

Code List

Patient Gender

CL Item

Female (Female)

C46110 (NCI Thesaurus)
C0086287 (UMLS 2011AA)

CL Item

Male (Male)

C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)

PatientPaymentType

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)

CL.6

Code List

Method of Payment

CL Item

Private Insurance (Private)

CL Item

Medicare (Medicare)

C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)

CL Item

Medicare And Private Insurance (Medicare and Private)

CL Item

Medicaid (Medicaid)

C0025071 (NCI Metathesaurus)

CL Item

Medicaid And Medicare (Medicaid and Medicare)

CL Item

No insurance (self-pay) (No insurance (self-pay))

CL Item

No Means Of Payment (no Insurance) (No insurance (no means))

CL Item

Other (Other, specify at registration)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Military Or Veterans Sponsored Nos (Veterans Admin)

CL Item

Military Sponsored (including Champus & Tricare) (Military)

PatientEthnicGroupSouthwestOncologyGroupCategory

Item

Patient's Ethnicity

text

C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16564 (NCI Thesaurus Property)
C0015031 (UMLS 2011AA Property)

CL.7

Code List

Patient's Ethnicity

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

No (not Spanish) (No (not Spanish))

CL Item

Yes, Mexican (Yes, Mexican)

CL Item

Yes, Puerto Rican (Yes, Puerto Rican)

CL Item

Yes, Cuban (Yes, Cuban)

CL Item

Yes, Central American (Yes, Central American)

CL Item

Yes, South American (Yes, South American)

CL Item

Yes, Other (Yes, Other)

CL Item

Yes, Nos (Yes, NOS)

Racial Group

Item

Patient's Race (select all that apply)

text

C25372 (NCI Thesaurus ValueDomain)
C0034510 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17049 (NCI Thesaurus Property)

CL.8

Code List

Patient's Race (select all that apply)

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)

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

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 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

Could Not Be Determined Or Unsure (unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Social Security Number

Item

Patient Social Security Number

float

C25337 (NCI Thesaurus ValueDomain)
C1301821 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25686 (NCI Thesaurus Property)

PatientAddressPostalCode

Item

Patient's ZIP Code

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)

PatientAddressCountryCode

Item

Country of Residence (if not USA) (If a resident of Canada)

text

PatientSocialInsuranceIdentifierNumber

Item

Social Insurance Number

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C62650 (NCI Thesaurus ObjectClass-2)
C0728831 (UMLS 2011AA ObjectClass-2)
C16745 (NCI Thesaurus ObjectClass-3)
C0021672 (UMLS 2011AA ObjectClass-3)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

CanadaAddressPostalCode

Item

Postal Code

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C16380 (NCI Thesaurus ObjectClass)
C0006823 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)

ClinicalStudyProtocolStratificationFactorsType

Item

Stratification factors

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C16153 (NCI Thesaurus Property)
C1514984 (UMLS 2011AA Property)

CL.9

Code List

Stratification factors

CL Item

Progression Of Measurable Or Evaluable Disease (Progression of measurable or evaluable disease)

CL Item

Psa Progression Only (PSA progression only)

ExtraskeletalMetastasisMalignantNeoplasmPresentInd-2

Item

Extraskeletal metastases

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C19151 (NCI Thesaurus ObjectClass)
C0027627 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)

PatientWorstPainRangeScale

Item

Worst pain (by Brief Pain Inventory)

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3303 (NCI Thesaurus Property)
C0030193 (UMLS 2011AA Property)
C25719 (NCI Thesaurus Property-2)
C1522166 (UMLS 2011AA Property-2)
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C38013 (NCI Thesaurus ValueDomain-2)
C1514721 (UMLS 2011AA ValueDomain-2)

CL.11

Code List

Worst pain (by Brief Pain Inventory)

CL Item

< 4 (< 4)

CL Item

>= 4 (>= 4)

CurrentTherapeuticProcedureBiphosphonateAdministeredInd-3

Item

Is the patient currently receiving bisphosphonate?

boolean

C25471 (NCI Thesaurus ObjectClass)
C0521116 (UMLS 2011AA ObjectClass)
C49236 (NCI Thesaurus ObjectClass-2)
C0087111 (UMLS 2011AA ObjectClass-2)
C443 (NCI Thesaurus Property)
C0012544 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

PriorRadicalProstatectomyPerformedInd-2

Item

Prior radical prostatectomy

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C0194810 (NCI Metathesaurus ObjectClass)

Miscellaneous Patient Information

Item Group

Miscellaneous Patient Information

IRB Approval Date

Item

IRB Approval Date

date

C25320 (NCI Thesaurus ObjectClass)
C2346500 (UMLS CUI-1)
C16741 (NCI Thesaurus Property)
C25425 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

Treatment Begin Date

Item

Projected Start Date of Treatment

date

C15368 (NCI Thesaurus ObjectClass)
C25631 (NCI Thesaurus ObjectClass-2)
C25431 (NCI Thesaurus Property)
C3173309 (UMLS CUI-1)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-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)

SouthwestOncologyGroupInvestigatorIdentifierNumber

Item

SWOG Investigator Number

float

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus ObjectClass)
C1519429 (UMLS 2011AA ObjectClass)
C17089 (NCI Thesaurus ObjectClass-2)
C0035173 (UMLS 2011AA ObjectClass-2)

OtherGroupInvestigatorIdentifierName

Item

Other Group Investigator Name

text

C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C25936 (NCI Thesaurus ObjectClass-2)
C0035173 (UMLS 2011AA ObjectClass-2)
C43359 (NCI Thesaurus ObjectClass-3)
C0441833 (UMLS 2011AA ObjectClass-3)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)

OtherGroupInvestigatorIdentifierNumber

Item

Other Group Investigator Number

text

C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C25936 (NCI Thesaurus ObjectClass-2)
C0035173 (UMLS 2011AA ObjectClass-2)
C43359 (NCI Thesaurus ObjectClass-3)
C0441833 (UMLS 2011AA ObjectClass-3)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

SouthwestOncologyGroupTreatingInstitutionIdentifierNumber

Item

SWOG Treating Institution Number (OR)

float

C25699 (NCI Thesaurus ObjectClass)
C1519429 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)
C41206 (NCI Thesaurus ObjectClass-3)
C1272753 (UMLS 2011AA ObjectClass-3)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

OtherGroupTreatingInstitutionIdentifierName

Item

Other Group Institution Name

text

C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)
C41206 (NCI Thesaurus ObjectClass-3)
C1272753 (UMLS 2011AA ObjectClass-3)
C43359 (NCI Thesaurus ObjectClass-4)
C0441833 (UMLS 2011AA ObjectClass-4)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
C0018704 (UMLS 2011AA ValueDomain-2)

OtherGroupTreatingInstitutionIdentifierNumber

Item

Other Group Institution Number

text

C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C25705 (NCI Thesaurus ObjectClass-2)
C1522326 (UMLS 2011AA ObjectClass-2)
C41206 (NCI Thesaurus ObjectClass-3)
C1272753 (UMLS 2011AA ObjectClass-3)
C43359 (NCI Thesaurus ObjectClass-4)
C0441833 (UMLS 2011AA ObjectClass-4)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

HIPAA Approval Date

Item

Date HIPAA Authorization signed (Not required for non-American sites)

date

C25164 (NCI Thesaurus ValueDomain)
C0600593 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2346844 (UMLS CUI-2)
C25425 (NCI Thesaurus Property)

PharmaceuticsOrganizationIdentifierNumber

Item

Pharmacy number

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C19711 (NCI Thesaurus ObjectClass)
C1522486 (UMLS 2011AA ObjectClass)
C16976 (NCI Thesaurus ObjectClass-2)
C0031336 (UMLS 2011AA ObjectClass-2)

PersonSpecimenMalignantNeoplasmResearchConsentInd-2

Item

My specimens may be kept for use in research to learn about, prevent, treat, or cure cancer.

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-3)
C0370003 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

SouthwestOncologyGroupPatientTissueSpecimenConsentInd-2

Item

My specimens may be kept for research about other health problems (for example: causes of diabetes, Alzheimer's disease, and heart disease.)

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25699 (NCI Thesaurus ObjectClass-2)
C1519429 (UMLS 2011AA ObjectClass-2)
C12801 (NCI Thesaurus Property)
C0040300 (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)

PatientAdditionalResearchConsentInd-2

Item

Someone may contact me in the future to ask me to take part in more research.

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C25406 (NCI Thesaurus Property-2)
C1524062 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

SouthwestOncologyGroupPatientResearchConsentInd-2

Item

I agree to allow my study doctor, or someone approved by my study doctor, to contact me regard future research involving my participation in this study

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25699 (NCI Thesaurus ObjectClass-2)
C1519429 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

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Southwest Oncology Group Registration Form (S0421) NCT00134056

No Instruction available.

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