ID

5666

Description

Southwest Oncology Group S0819 Prestudy Form Carboplatin and Paclitaxel With or Without Bevacizumab and/or Cetuximab in Treating Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=684FE956-5AAF-A7DA-E040-BB89AD432A2B

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=684FE956-5AAF-A7DA-E040-BB89AD432A2B

Keywords

Carcinoma, Non-Small-Cell Lung

Pre-Study Form

Uploaded on

August 11, 2014

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Lung Cancer NCT00946712 Pre-Study - Southwest Oncology Group S0819 Prestudy Form - 2863901v1.0

model
Details

Instructions: Submit this form within 14 days of registration. All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across top of form

1 forms

StudyEvent: Southwest Oncology Group S0819 Prestudy Form
1. Instructions: Submit this form within 14 days of registration. All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across top of form

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Header Module

Item Group

Unnamed1

PatientSouthwestOncologyGroupIdentifierNumber

Item

SWOG Patient ID

double

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property)
C1519429 (UMLS 2011AA Property)

ProtocolSWOGIdentifierNumber

Item

SWOG Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25699 (NCI Thesaurus Property)
C1519429 (UMLS 2011AA Property)

RegistrationStepNumber

Item

Registration Step

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C16154 (NCI Thesaurus Property)
C1704379 (UMLS 2011AA Property)
C16154 (NCI Thesaurus ValueDomain)
C1704379 (UMLS 2011AA ValueDomain)

PatientInitialsName

Item

Patient Initials (L, F M)

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)

CombinedInstitutionName

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)

RegisteredInvestigatorName

Item

Physician

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)
C25644 (NCI Thesaurus ObjectClass)

ParticipatingGroupName

Item

Participating Group Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

ProtocolParticipatingIdentifierNumber

Item

Participating Group Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PatientParticipatingIdentifierNumber

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PATIENT AND DISEASE DESCRIPTION

Item Group

Patient And Disease Description

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Item

Performance Status

text

C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)

CL.1

Code List

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)

CL Item

Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)

CL Item

Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)

CL Item

Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)

CL Item

Dead (5)

PatientHeightMeasurement

Item

Height (cm)

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)

PatientWeightMeasurement

Item

Weight (kg)

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA Property)

PersonBodySurfaceAreaValue

Item

BSA (m^2)

double

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS 2011AA Property)

CurrentDiseaseDiagnosisStatus

Item

Type of Patient Disease

text

C25471 (NCI Thesaurus ObjectClass)
C0521116 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.2

Code List

Type of Patient Disease

CL Item

New Diagnosis (New diagnosis)

CL Item

Recurrent After Surgery Or Radiation (Recurrent after surgery or radiation)

LungTumorHistologicClassificationLungTumorHistologicCategory

Item

Histology

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)

CL.3

Code List

Histology

CL Item

Squamous Cell Carcinoma (Squamous cell carcinoma)

C2929 (NCI Thesaurus)
C0007137 (UMLS 2011AA)

CL Item

Adenocarcinoma (Adenocarcinoma)

C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)

CL Item

Large Cell Carcinoma (Large cell carcinoma)

C3780 (NCI Thesaurus)
C0206704 (UMLS 2011AA)

CL Item

Bronchoalveolar (bac) (Bronchoalveolar carcinoma (BAC))

CL Item

Mixed >= 50% Squamous Cell Carcinoma (Mixed >= 50% squamous cell carcinoma)

CL Item

Mixed < 50% Squamous Cell Carcinoma (Mixed < 50% squamous cell carcinoma)

CL Item

Non-small Cell Lung Carcinoma (Other Non-Small Cell Lung Cancer)

C2926 (NCI Thesaurus)
C0007131 (UMLS 2011AA)

TumorHistologicCategorySpecify

Item

Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)

LungTumorClinicalTStage

Item

Clinical T Stage

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property)
C0475455 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.4

Code List

Clinical T Stage

CL Item

No Evidence Of Primary Tumor (T0)

CL Item

Tumor 3 Cm Or Less In Greatest Dimension, Surrounded By Lung Or Visceral Pleura, Invasion More Proximal Than The Lobar Bronchus, (i.e., Not In The Main Bronchus) (T1)

CL Item

Tumor With Any Of The Following Features Of Size Or Extent: More Than 3cm In Greatest Dimension; Invades The Visceral Pleura; Associated With Atelectasis Or Obstructive Pneumonitis That Extends To The Hilar Region But Does Not Involve The Entire Lung (T2)

CL Item

Tumor Of Any Size That Directly Invades Any Of The Following: Chest Wall (including Superior Sulcus Tumors), Diaphragm, Mediastinal Pleura, Parietal Pericardium; Or Tumor In The Main Bronchus Less Than 2 Cm Distal To The Carina, But Without Involvement O* (T3)

CL Item

Carcinoma In Situ (Tis)

C2917 (NCI Thesaurus)
C0007099 (UMLS 2011AA)

CL Item

Primary Tumor Cannot Be Assessed, Or Tumor Proven By The Presence Of Malignant Cells In Sputum Or Bronchial Washings But Not Visualized By Imaging Or Bronchoscopy (Tx)

LungTumorClinicalNStage

Item

Clinical N Stage

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property)
C0456532 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.5

Code List

Clinical N Stage

CL Item

No Regional Lymph Node Metastasis (N0)

CL Item

Metastasis To Ipsilateral Peribronchial And/or Ipsilateral Hilar Lymph Nodes, And Intrapulmonary Nodes Including Involvement By Direct Extension Of The Primary Tumor (N1)

CL Item

Metastasis To Ipsilateral Mediastinal And/or Subcarinal Lymph Node(s) (N2)

CL Item

Metastasis To Contralateral Mediastinal, Contralateral Hilar, Ipsilateral Or Contralateral Scalene, Or Supraclavicular Lymph Node(s) (N3)

CL Item

Regional Lymph Nodes Cannot Be Assessed (NX)

LungTumorClinicalMStage

Item

Clinical M Stage

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property)
C0456533 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C39315 (NCI Thesaurus ValueDomain)
C1515946 (UMLS 2011AA ValueDomain)

CL.6

Code List

Clinical M Stage

CL Item

No Distant Metastasis (no Pathologic M0; Use Clinical M To Complete Stage Group) (M0)

CL Item

Separate Tumor Nodule(s) In A Contralateral Lobe; Tumor With Pleural Nodules Or Malignant Pleural (or Pericardial) Effusion (M1a)

CL Item

Distant Metastasis (M1b)

C18206 (NCI Thesaurus)
C1269798 (UMLS 2011AA)
C18206 (NCI Thesaurus)
C1269798 (UMLS 2011AA)

MalignantPleuralEffusionMalignantPericardialEffusionPresentInd-2

Item

If M1a, was this staging due to pericardial/pleural effusion only

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C7717 (NCI Thesaurus ObjectClass)
C0220655 (UMLS 2011AA ObjectClass)
C9432 (NCI Thesaurus ObjectClass)
C0080032 (UMLS 2011AA ObjectClass)

CL.7

Code List

If M1a, was this staging due to pericardial/pleural effusion only

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PATIENT AND DISEASE DESCRIPTION1

Item Group

Patient And Disease Description1

Smoking history

Item

Smoking History

text

C25180 (NCI Thesaurus ValueDomain)
C1519384 (UMLS CUI-1)
C17934 (NCI Thesaurus ObjectClass)
C18772 (NCI Thesaurus Property)

CL.8

Code List

Smoking History

CL Item

Current (Current)

C25471 (NCI Thesaurus)
C0521116 (UMLS 2011AA)

CL Item

Former (Former)

C0750523 (NCI Metathesaurus)

CL Item

Never (Never)

C70543 (NCI Thesaurus)
C2003901 (UMLS 2011AA)

HemoptysisPresentInd-2

Item

Does patient have a history of hemoptysis

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3094 (NCI Thesaurus ObjectClass)
C0019079 (UMLS 2011AA ObjectClass)

CL.9

Code List

Does patient have a history of hemoptysis

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

HemoptysisPresentMeasurement

Item

Amount of hemoptysis (If yes, teaspoons)

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3094 (NCI Thesaurus ObjectClass)
C0019079 (UMLS 2011AA ObjectClass)

HemoptysisPresentDate

Item

Date hemoptysis assessed (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3094 (NCI Thesaurus ObjectClass)
C0019079 (UMLS 2011AA ObjectClass)

MagneticResonanceImagingComputedTomographyBrainMedicalImagingPriorTherapyAssessmentDate

Item

Date of pre-treatment CT/MRI of brain (MM DD YYYY)

date

C17204 (NCI Thesaurus ObjectClass)
C0040405 (UMLS 2011AA ObjectClass)
C12439 (NCI Thesaurus ObjectClass)
C0006104 (UMLS 2011AA ObjectClass)
C16809 (NCI Thesaurus ObjectClass)
C0024485 (UMLS 2011AA ObjectClass)
C16831 (NCI Thesaurus ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15368 (NCI Thesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

MalignantCentralNervousSystemNeoplasmMetastasisClinicalEvidencePresentInd-2

Item

Does the patient have clinical evidence of CNS metastases

text

C19151 (NCI Thesaurus ObjectClass)
C0027627 (UMLS 2011AA ObjectClass)
C4627 (NCI Thesaurus ObjectClass)
C0348374 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C43583 (NCI Thesaurus Property)
C0332120 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.10

Code List

Does the patient have clinical evidence of CNS metastases

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

ConcomitantDiseasePersonalMedicalHistoryType

Item

Medical History

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25730 (NCI Thesaurus ObjectClass)
C0521115 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)

CL.11

Code List

Medical History

CL Item

Open Biopsy (Open biopsy)

CL Item

Core Biopsy (Core biopsy)

C15680 (NCI Thesaurus)
C1318309 (UMLS 2011AA)

CL Item

Significant Traumatic Injury (Significant traumatic injury)

CL Item

Abdominal Fistula (Abdominal fistula)

CL Item

Gastrointestinal Perforation (Gastrointestinal perforation)

CL Item

Intra-abdominal Abscess (Intra-abdominal abscess)

PatientPre-ExistingConditionMostRecentDate

Item

Date of most recent event (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25577 (NCI Thesaurus ValueDomain)
C1513491 (UMLS 2011AA ValueDomain)
CL232826 (NCI Metathesaurus Property)

LABORATORY VALUES

Item Group

Laboratory Values

LaboratoryProcedureAbsoluteNeutrophilCountResultUnspecifiedValue

Item

ANC (mcl)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C63321 (NCI Thesaurus Property)
C0948762 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedurePlateletResultUnspecifiedValue

Item

Peripheral Platelet Count (mcl)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property)
C0005821 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureHemoglobinResultUnspecifiedValue

Item

Hemoglobin (mg/dL)

double

C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

MalignantNeoplasmLiverMetastaticInvolvementInd-3

Item

Liver metastases (Hepatic)

text

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12392 (NCI Thesaurus Property)
C0023884 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.12

Code List

Liver metastases (Hepatic)

CL Item

No (NO)

CL Item

Yes (YES)

LaboratoryProcedureTotalBilirubinResultUnspecifiedValue

Item

Total Bilirubin (mg/dL)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureTotalBilirubinResultUpperLimitNormalValue

Item

Total Bilirubin ULN (mg/dL)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C38037 (NCI Thesaurus Property)
C0201913 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedValue

Item

SGOT (U/L)

double

C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Item

SGOT (AST) ULN (U/L)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUnspecifiedValue

Item

SGPT (U/L)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property)
C0376147 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

Item

SGPT (ALT) ULN (U/L)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property)
C0376147 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)

SpecimenCollectedDate

Item

Collection Date (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

SpecimenCollectedDate

Item

Collection Date (MM DD YYYY)

date

SpecimenCollectedDate

Item

Collection Date (MM DD YYYY)

date

SpecimenCollectedDate

Item

Collection Date (MM DD YYYY)

date

SpecimenCollectedDate

Item

Collection Date (MM DD YYYY)

date

SpecimenCollectedDate

Item

Collection Date (MM DD YYYY)

date

LABORATORY VALUES1

Item Group

Laboratory Values1

LaboratoryProcedureCreatinineResultUnspecifiedValue

Item

Serum Creatinine (mg/dL Renal)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureCreatinineResultUpperLimitofNormalValue

Item

Serum Creatinine ULN (mg/dL Renal)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)

LaboratoryProcedureCreatinineClearanceOutcomeValue

Item

Creatinine Clearance (ml/min Measured Renal)

double

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25747 (NCI Thesaurus Property)
C0373595 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureCreatinineClearanceOutcomeEstimateValue

Item

Creatinine clearance (calculated) (ml/min Renal)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25747 (NCI Thesaurus Property)
C0373595 (UMLS 2011AA Property)
C25498 (NCI Thesaurus ValueDomain)
C0750572 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

UrinaryCreatinineProteinAssessmentValue

Item

Urine Protein/Creatinine Ratio (Renal)

double

C25711 (NCI Thesaurus ObjectClass)
C1524119 (UMLS 2011AA ObjectClass)
C17021 (NCI Thesaurus ObjectClass)
C0033684 (UMLS 2011AA ObjectClass)
C0010294 (NCI Metathesaurus ObjectClass)
C25367 (NCI Thesaurus Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

UrinaryProteinCollectionValue

Item

Protein from 24 hour Urine Collection (mg/24-hours If UPC > 0.5, Renal)

double

C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C17021 (NCI Thesaurus ObjectClass)
C0033684 (UMLS 2011AA ObjectClass)

LaboratoryProcedureInternationalNormalizationRatioResultValue

Item

INR (Coagulation)

double

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25352 (NCI Thesaurus Property)
C0525032 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureInternationalNormalizationRatioResultUpperLimitofNormalValue

Item

INR ULN (Coagulation)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25352 (NCI Thesaurus Property)
C0525032 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)

LaboratoryProcedureAlbuminResultUnspecifiedValue

Item

Albumin (g/dL)

double

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C214 (NCI Thesaurus Property)
C0001924 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureLactateDehydrogenaseResultUnspecifiedValue

Item

LDH (U/L)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25184 (NCI Thesaurus Property)
C0022917 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

SpecimenCollectedDate

Item

Collection Date (MM DD YYYY)

date

SpecimenCollectedDate

Item

Collection Date (MM DD YYYY)

date

SpecimenCollectedDate

Item

Collection Date (MM DD YYYY)

date

SpecimenCollectedDate

Item

Collection Date (MM DD YYYY)

date

SpecimenCollectedDate

Item

Collection Date (MM DD YYYY)

date

LaboratoryProcedureLactateDehydrogenaseResultUpperLimitofNormalValue

Item

LDH, ULN (U/L)

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25184 (NCI Thesaurus Property)
C0022917 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)

ADDITIONAL PRESTUDY DATA

Item Group

Additional Prestudy Data

PatientWeightLossPercentageScale

Item

Weight Loss in Previous Six Months (Estimated)

text

C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3445 (NCI Thesaurus Property)
C0043096 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)

CL.13

Code List

Weight Loss in Previous Six Months (Estimated)

CL Item

<5% Of Body Weight (< 5% of body weight)

CL Item

5 To <10% Of Body Weight (5 to < 10% of body weight)

CL Item

10 To <20% Of Body Weight (10 to <20% of body weight)

CL Item

> Or = 20% Of Body Weight (> or = 20% of body weight)

PatientHemorrhagePre-ExistingConditionInd-3b

Item

Does the patient have a history of hemorrhagic diasthesis or coagulopathy

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C26791 (NCI Thesaurus Property)
C0019080 (UMLS 2011AA Property)
CL232826 (NCI Metathesaurus Property)
C49797 (NCI Thesaurus ValueDomain)
C1708496 (UMLS 2011AA ValueDomain)

CL.14

Code List

Does the patient have a history of hemorrhagic diasthesis or coagulopathy

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

FullDoseAnticoagulantAgentCurrentUseInd-2

Item

Is the patient receiving therapeutic anticoagulation, or regularly using aspirin at > 325 mg per day, or using non-steroidal anti-inflammatory agents, or other agents known to inhibit platelet function

text

C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C263 (NCI Thesaurus ObjectClass)
C0003280 (UMLS 2011AA ObjectClass)
C25517 (NCI Thesaurus ObjectClass)
C0443225 (UMLS 2011AA ObjectClass)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.15

Code List

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Item

Does patient have a non-healing wound, ulcer, bone fracture, abdominal fistula, GI perforation, or intraabdominal abscess

text

C25648 (NCI Thesaurus ObjectClass)
C0439849 (UMLS 2011AA ObjectClass)
C3671 (NCI Thesaurus ObjectClass)
C0043250 (UMLS 2011AA ObjectClass)
C2959 (NCI Thesaurus Property)
C0009566 (UMLS 2011AA Property)
C41130 (NCI Thesaurus Property)
C0750502 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.16

Code List

Does patient have a non-healing wound, ulcer, bone fracture, abdominal fistula, GI perforation, or intraabdominal abscess

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PatientPulmonaryLesionPersonalMedicalHistoryInd-2

Item

Does patient have a cavitary pulmonary lesion

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3824 (NCI Thesaurus Property)
C0221198 (UMLS 2011AA Property)
C13304 (NCI Thesaurus Property)
C2709248 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.17

Code List

Does patient have a cavitary pulmonary lesion

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PRIOR TREATMENT RELATED TO THIS CANCER

Item Group

Prior Treatment Related To This Cancer

SWOGPriorTherapyAdministeredType

Item

Prior Therapy Type (s select all that apply)

text

C25699 (NCI Thesaurus ObjectClass)
C1519429 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.18

Code List

Prior Therapy Type (s select all that apply)

CL Item

Adjuvant Systemic Therapy (Adjuvant systemic therapy)

CL Item

Radiotherapy (Radiotherapy)

CL Item

Surgery (Surgery)

C17173 (NCI Thesaurus)
C0038894 (UMLS 2011AA)

AdjuvantTherapyPriorEndDate

Item

Date prior adjuvant systemic therapy completed (MM DD YYYY)

date

C15368 (NCI Thesaurus ObjectClass)
C2140 (NCI Thesaurus ObjectClass)
C0001552 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

PriorRTEndDate

Item

Date Prior RT Ended (MM DD YYYY)

date

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25496 (NCI Thesaurus Property)
C2746065 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

SurgicalProcedurePriorMajorPerformedDate

Item

Date of last prior major surgery (MM DD YYYY)

date

C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C45368 (NCI Thesaurus Property)
C0205164 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

PrimarySurgeryPriorPerformedDate

Item

Date of last prior core biopsy, mediastinoscopy, pleurodesis or VATS pericardial window (MM DD YYYY)

date

C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

PriorMinorSurgicalProcedurePerformedDate

Item

Date of last prior biopsy or surgical procedure (not specified above MM DD YYYY)

date

C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C45367 (NCI Thesaurus Property)
C0205165 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

Comments

Item Group

Comments

ResearchCommentsText

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)

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Lung Cancer NCT00946712 Pre-Study - Southwest Oncology Group S0819 Prestudy Form - 2863901v1.0

Instructions: Submit this form within 14 days of registration. All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across top of form

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