ID

7897

Description

Unknown Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=109F4E7D-3810-226A-E044-0003BA3F9857

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=109F4E7D-3810-226A-E044-0003BA3F9857

Mots-clés

Klinische Studie [Dokumenttyp]

Lung

On-Study Form

Téléchargé le

9 janvier 2015

DOI

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Creative Commons BY-NC 3.0 Legacy

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On-Study - Unknown ECOG Lung Onstudy - 2468160v1.0

model
Détails

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files

1 Formulaires

StudyEvent: Unknown ECOG Lung Onstudy
1. INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files

Name

Type

Description | Question | Decode (Coded Value)

Type de données

Alias

Header

Item Group

Header

Protocol Number ECOG

Item

ECOG Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Patient ID ECOG

Item

ECOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Generic drug form

Item

DCI Name

text

C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-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)

Clinical Trial Period

Item

Reporting Period

text

C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)

CL.1

Code List

Reporting Period

CL Item

Baseline (Baseline)

C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)

Unnamed2

Item Group

Unnamed2

Patient Initials

Item

Patient Initials (Last, First)

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)

Protocol Number ECOG

Item

ECOG Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Patient ID ECOG

Item

ECOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

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)

Trial subject ID Participating Group

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Institution Name

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)

Unnamed 3

Item Group

Unnamed 3

Data amended

Item

Please mark an 'X' if data have been amended (Please circle amended items in red)

text

C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)

Data amended date

Item

Date data amended (M D Y)

date

C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)

Pre-Treatment Characteristics

Item Group

Unnamed3

ECOG Performance Status

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)

CL.2

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)

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)

Patient Height

Item

Height (cm)

float

C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)

Patient Weight

Item

Weight (kg)

float

C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)

Weight Loss past six months

Item

Weight Loss in Previous Six Months

text

C25664 (NCI Thesaurus ValueDomain)
C0043096 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C3828652 (UMLS CUI-2)
C3445 (NCI Thesaurus Property)
C25613 (NCI Thesaurus ValueDomain-2)

CL.3

Code List

Weight Loss in Previous Six Months

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 -<20% of body weight)

CL Item

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

NSCLC Disease Description

Item Group

Description Of Disease At Initial Diagnosis

CancerInitialDiagnosisDate

Item

Date of initial pathologic diagnosis (M D Y)

date

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

Histologic Type

Item

Histologic Type

text

C3262 (NCI Thesaurus ObjectClass)
C0449574 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C25526 (NCI Thesaurus Property)
C25161 (NCI Thesaurus Property-2)
C25372 (NCI Thesaurus ValueDomain)
C25526 (NCI Thesaurus ValueDomain-2)

CL.4

Code List

Histologic Type

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

Non-small Cell Lung Cancer (nsclc), Nos (Non-small cell lung cancer NOS)

CL Item

Combined/mixed, Specify Subcategories (Combined/mixed)

CL Item

Other (Other specify)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C17649 (NCI Thesaurus-3)
C0205394 (UMLS 2011AA-4)

LungNeoplasmCombinedMixedHistologyClassificationSpecify

Item

Specify combined/mixed histologic types

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass-2)
C0024109 (UMLS 2011AA ObjectClass-2)
C25454 (NCI Thesaurus Property)
C0205195 (UMLS 2011AA Property)
C25259 (NCI Thesaurus Property-2)
C0205430 (UMLS 2011AA Property-2)
C25526 (NCI Thesaurus Property-3)
C0205462 (UMLS 2011AA Property-3)
C25161 (NCI Thesaurus Property-4)
C0008902 (UMLS 2011AA Property-4)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

Histologic Type, other

Item

Specify Other Histologic Type

text

C25685 (NCI Thesaurus ValueDomain)
C1299220 (UMLS CUI-1)
C3262 (NCI Thesaurus ObjectClass)
C25526 (NCI Thesaurus Property)
C25161 (NCI Thesaurus Property-2)

TumorLungAreaType

Item

Tumor Location Area

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus Property)
C0024109 (UMLS 2011AA Property)
C25244 (NCI Thesaurus Property-2)
C0205146 (UMLS 2011AA Property-2)

CL.5

Code List

Tumor Location Area

CL Item

Upper Lobe (right) (Upper Lobe (right))

CL Item

Middle Lobe (right) (Middle Lobe (right))

CL Item

Lower Lobe (right) (Lower Lobe (right))

CL Item

Upper Lobe (left) (Upper Lobe (left))

CL Item

Lingula (Lingula)

CL Item

Lower Lobe (left) (Lower Lobe (left))

CL Item

Other, Specify (Other)

DiseaseInvolvedSiteSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25547 (NCI Thesaurus Property-2)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

DataUnknownText

Item

Data Unknown Text

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C17998 (NCI Thesaurus Property)
C0439673 (UMLS 2011AA Property)

Tumor Stage

Item

Stage (as determined by surgical evaluation)

text

C3262 (NCI Thesaurus ObjectClass)
C1300072 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C16899 (NCI Thesaurus ValueDomain)
C25523 (NCI Thesaurus Property)

CL.6

Code List

Stage (as determined by surgical evaluation)

CL Item

Ib- T2n0 (IB- T2N0)

CL Item

Iia- T1n1 (IIA- T1N1)

CL Item

Iib- T2n1 (IIB- T2N1)

CL Item

Iib- T3n0 (IIB- T3N0)

CL Item

Iiia- T1n2 (IIIA- T1N2)

CL Item

Iiia- T2n2 (IIIA- T2N2)

CL Item

Iiia- T3n1 (IIIA- T3N1)

CL Item

Iiia- T3n2 (IIIA- T3N2)

ChemotherapyRegimenType

Item

Chemotherapy Regimen

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)

CL.7

Code List

Chemotherapy Regimen

CL Item

Carboplatin And Paclitaxel (Carboplatin and Paclitaxel)

CL Item

Cisplatin And Vinorelbine (Cisplatin and Vinorelbine)

CL Item

Cisplatin And Docetaxel (Cisplatin and Docetaxel)

CL Item

Cisplatin And Gemcitabine (Cisplatin and Gemcitabine)

Resection Information

Item Group

History Of Disease

LungResectionType

Item

Resection Type

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C15232 (NCI Thesaurus Property)
C0728940 (UMLS 2011AA Property)

CL.8

Code List

Resection Type

CL Item

Intrapericardial Pneumonectomy (Intrapericardial pneumonectomy)

CL Item

Pneumonectomy (Pneumonectomy)

C15305 (NCI Thesaurus)
C0032284 (UMLS 2011AA)

CL Item

Lobectomy (Lobectomy)

C15272 (NCI Thesaurus)
C0023928 (UMLS 2011AA)

CL Item

Bilobectomy (Bilobectomy)

CL Item

Sleeve Lobectomy (Sleeve lobectomy)

CL Item

Lobectomy And Chest Wall Resection (Lobectomy and chest wall resection)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

LungResectionSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C15232 (NCI Thesaurus Property)
C0728940 (UMLS 2011AA Property)

PatientSurgicalResectionDate

Item

Date of Resection

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25698 (NCI Thesaurus Property)
C15232 (NCI Thesaurus Property-2)
C0728940 (UMLS 2011AA Property)

MediastinalLymphNodePhysicalExaminationType

Item

Type of Mediastinal Lymph Node Dissection

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25310 (NCI Thesaurus ObjectClass-2)
C1522718 (UMLS 2011AA ObjectClass-2)

CL.9

Code List

Type of Mediastinal Lymph Node Dissection

CL Item

None (None)

C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)

CL Item

Incomplete Sampling (Incomplete sampling)

CL Item

Systematic Sampling (Systematic sampling)

CL Item

Complete Mediastinal Lymph Node Dissection (Complete mediastinal lymph node dissection)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

MediastinalLymphNodePhysicalExaminationSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25310 (NCI Thesaurus ObjectClass-2)
C1522718 (UMLS 2011AA ObjectClass-2)

MediastinalLymphNodePhysicalExaminationDate

Item

Date of Lymph Node Dissection

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25310 (NCI Thesaurus ObjectClass-2)
C1522718 (UMLS 2011AA ObjectClass-2)

PreoperativeMediastinoscopyPerformedInd-2

Item

Pre-operative mediastinoscopy

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16829 (NCI Thesaurus ObjectClass)
C0025065 (UMLS 2011AA ObjectClass)
C54732 (NCI Thesaurus ObjectClass-2)
C0445204 (UMLS 2011AA ObjectClass-2)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)

PreoperativeMediastinoscopyPerformedDate

Item

Date (If yes)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16829 (NCI Thesaurus ObjectClass)
C0025065 (UMLS 2011AA ObjectClass)
C54732 (NCI Thesaurus ObjectClass-2)
C0445204 (UMLS 2011AA ObjectClass-2)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)

LymphNodeInvolvementType

Item

Involvement

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)

CL.11

Code List

Involvement

CL Item

Negative (negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Unknown (unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

LungLymphNodeInvolvementStatus

Item

Node Levels

text

C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C12745 (NCI Thesaurus ObjectClass-2)
C0024204 (UMLS 2011AA ObjectClass-2)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.12

Code List

Node Levels

CL Item

2r (2R)

CL Item

4r (4R)

CL Item

10r (10R)

CL Item

11r (11R)

CL Item

12-13r (12-13R)

CL Item

1 (1)

CL Item

3 (3)

CL Item

5 (5)

CL Item

6 (6)

CL Item

7 (7)

CL Item

2l (2L)

CL Item

10l (10L)

CL Item

11l (11L)

CL Item

12-13l (12-13L)

PatientWoundComplicationPersonalMedicalHistoryInd-2

Item

Does the patient have a history of wound healing complications (Patients must have recovered from any wound healing complications prior to study entry)

boolean

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3671 (NCI Thesaurus Property)
C0043250 (UMLS 2011AA Property)
C2959 (NCI Thesaurus Property-2)
C0009566 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PatientWoundComplicationPersonalMedicalHistorySpecify

Item

Specify (If yes:)

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3671 (NCI Thesaurus Property)
C0043250 (UMLS 2011AA Property)
C2959 (NCI Thesaurus Property-2)
C0009566 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

AdverseEventMostRecentRecoveryDate

Item

Recovery or Latest Date (last known date of disease activity - M D Y)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25746 (NCI Thesaurus Property)
C2004454 (UMLS 2011AA Property)
C25577 (NCI Thesaurus Property-2)
C1513491 (UMLS 2011AA Property-2)

Baseline Abnormalities

Item Group

Baseline Abnormalities

CTC Adverse Event Term

Item

CTC Adverse Event Term Type (include subterm if applicable Use CTCAE v3 terminology)

text

C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)

CTC Adverse Event Grade

Item

CTC Adverse Event Grade (Use grade 1-4 per CTCAE v3)

float

C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)

Footer Module

Item Group

Comments

Investigator Signature

Item

Investigator Signature

text

C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)

Investigator Signature Date

Item

Investigator Signature Date

date

C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)

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Modèle Commentaires :

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On-Study - Unknown ECOG Lung Onstudy - 2468160v1.0

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files

Description

Description

Type de données

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