ID

43385

Descrição

Form 1 - Eligibility Checklist and Initial Evaluation Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed NCT00049543 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A7422C05-78BD-5678-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A7422C05-78BD-5678-E034-0003BA0B1A09

Palavras-chave

Lungentumoren

Klinische Studie [Dokumenttyp]

Behandlungsbedürftigkeit, Begutachtung

Baseline

Transferido a

20 de setembro de 2021

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0 Legacy

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NSCLC (NCT00049543)

model
Detalhes

No Instruction available.

1 Formulários

StudyEvent: Form 1 - Eligibility Checklist and Initial Evaluation
1. No Instruction available.

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

PATIENT INFORMATION

Item Group

Patient Information

C1955348 (UMLS CUI-1)

PatientStudyID,CoordinatingGroup

Item

Patient Study ID, Coordinating Group

text

Patient Initials

Item

Patient Initials

text

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

PatientMedicalRecordNumber

Item

Patient Medical Record Number

text

InstitutionName

Item

Institution Name

text

RegisteredInvestigator

Item

Registered Investigator (NCI Investigator #)

text

Birth Date

Item

Patient's Date of Birth (yyyy mmm dd)

date

C16960 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C0421451 (UMLS CUI-1)

PatientGender

Item

Patient Gender

text

C25372 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C17357 (NCI Thesaurus Property)
C0683312 (UMLS CUI-1)
C0030705 (UMLS CUI-2)
C0079399 (UMLS CUI-3)

CL.9

Code List

Patient Gender

CL Item

Male (Male)

C46109 (NCI Thesaurus)
C0086582 (UMLS CUI-1)

CL Item

Female (Female)

C46110 (NCI Thesaurus)
C0086287 (UMLS CUI-1)

PatientRace

Item

Patient Race (check _ all that apply)

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS 2011AA Property)

CL.2

Code List

Patient Race (check _ all that apply)

CL Item

White_cdus (White)

CL Item

Black_cdus (Black or African American)

CL Item

Pacific_islander_cdus (Native Hawaiian or other Pacific Islander)

CL Item

Asian_cdus (Asian)

CL Item

Native_american_cdus (American Indian or Alaska Native)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PatientEthnicity

Item

Patient Ethnicity (check _ one only)

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS 2011AA Property)

CL.3

Code List

Patient Ethnicity (check _ one only)

CL Item

Hispanic_or_latino (Hispanic or Latino)

CL Item

Non_hispanic (Non-Hispanic)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PaymentMethod

Item

Payment Method (check _ one USA only)

text

CL.4

Code List

Payment Method (check _ one USA only)

CL Item

Private Insurance (Private Insurance)

CL Item

Medicare (Medicare)

C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)

CL Item

Medicare And Private Insurance (Medicare/Private Insurance)

CL Item

Medicaid (Medicaid)

C0025071 (NCI Metathesaurus)

CL Item

Medicaid And Medicare (Medicaid & Medicare)

CL Item

Military Or Veterans Sponsored Nos (Military or Veterans Sponsored NOS)

CL Item

Military Sponsored (including Champus & Tricare) (Military Sponsored (including CHAMPUS and TRICARE))

CL Item

Veterans Sponsored (Veterans Sponsored)

CL Item

Self Pay (no Insurance) (Self pay (no insurance))

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

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

IRBApprovalDate

Item

IRB/REB Approval Date (yyyy mmm dd)

date

C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25425 (NCI Thesaurus Property)
C0205540 (UMLS 2011AA Property)

ProjectedTreatmentBeginDate

Item

Projected Start Date of Treatment (yyyy mmm dd)

date

LoggedEntryInitials

Item

Logged

text

LoggedEntryDate

Item

Logged Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS CUI-1)

RegulatoryAffairsReviewInitials

Item

text

RegulatoryAffairsReviewDate

Item

RA Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS CUI-1)

CoordinatorReviewInitials

Item

Study Coord

text

CoordinatorReviewDate

Item

Coord Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS CUI-1)

PhysicianReviewInitials

Item

Phy

text

DataEntryInitials

Item

Data Ent'd

text

DataVerificationInitials

Item

Verified

text

ELIGIBILITY CHECKLIST

Item Group

Eligibility Checklist

Lung neoplasm

Item

Patient has histological proof of a primary non-small cell lung cancer (bronchoalveolar carcinomas presenting as a discrete radiological mass or node are eligible. Please specify)

boolean

C0242379 (UMLS CUI-1)

HistologicType

Item

Histologic Type

integer

C0449574 (UMLS CUI-1)

CL.27

Code List

Histologic Type

CL Item

Squamous cell carcinoma (1)

C0007137 (UMLS CUI-1)

CL Item

Adenocarcinoma (2)

C0001418 (UMLS CUI-1)

CL Item

Adenosquamous carcinoma (3)

C0206623 (UMLS CUI-1)

CL Item

Large cell undifferentiated (4)

C0345958 (UMLS CUI-1)

CL Item

Other, Specify (5)

C1299220 (UMLS CUI-1)

PathologicStagePostoperativeInd

Item

Post operatively the patient had a pathological stage of

text

StageGrouping

Item

Stage

text

CL.11

Code List

Stage

CL Item

Refer To Figo Staging For Specific Gynecologic Cancer (IB)

CL Item

Refer To Figo Staging For Specific Gynecologic Cancer (II)

CL Item

Refer To Figo Staging For Specific Gynecologic Cancer (IIIA)

LymphNodeAdequateSamplingInd

Item

Adequate Lymph Node sampling was performed (see section 5.1.1.4 of the protocol)

text

LymphNodeSamplingExtent

Item

Please specify the extent of lymph node sampling (check _ one only)

text

CL.7

Code List

Please specify the extent of lymph node sampling (check _ one only)

CL Item

Complete Mediastinal Resection (Complete mediastinal resection)

CL Item

Partial Mediastinal Resection (Partial mediastinal resection)

CL Item

Nodes >= 1.5 Cm Were Sampled (Nodes >= 1.5 cm were sampled)

CL Item

No Enlarged Lymph Nodes On Ct Chest, No Mediastinal Sampling Done (No enlarged lymph nodes on CT chest, no mediastinal sampling done)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

LymphNodeSamplingExtentLargeSite

Item

Nodes >= 1.5 cm were sampled (specify)

text

LymphNodeSamplingOtherExtent

Item

Other (specify)

text

LungCarcinomaSurgicalProcedureTherapyInd-3

Item

Surgery consisted of lobectomy, sleeve resection, bilobectomy or pneumonectomy. (segmentectomy or wedge resection only is not eligible)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15329 (NCI Thesaurus Property)
C0543467 (UMLS 2011AA Property)
C4878 (NCI Thesaurus ObjectClass)
C0684249 (UMLS 2011AA ObjectClass)

GrossDiseaseRemovedInd

Item

Patient has had all gross disease surgically removed.

text

SurgicalResectionNegativeMarginIndicator

Item

All surgical margins of resection are negative for tumour.

text

MaximumTimePostSurgeryIndicator

Item

No more than 16 weeks may have elapsed between surgical resection and randomization.

text

SurgeryDate

Item

Surgery Date

date

C1628561 (UMLS CUI-1)

TumorBlocksSentIndicator

Item

A representative formalin fixed paraffin block of tumour tissue must be submitted at the request of the central tumour bank in order that specific EGFR correlative marker assays may be conducted.

text

MinimumPerformanceStatusIndicator

Item

Performance Status is <= 2. (see protocol appendix II)

text

RequiredHematology14DaysIndicator

Item

Required hematologic and biochemistry investigations done within 14 days prior to randomization, including:

text

Lab,Hematology,SampleCollectionDate

Item

Date Hematology (Blood) Sample Obtained (yyyy mmm dd)

date

WBC

Item

Peripheral WBC Count

float

C0023508 (UMLS CUI-1)

Lab,Hematology,NeutrophilCount

Item

Peripheral neutrophil count (>= 1.5 x 10 9/L or >= 1500/uL; Value)

float

Lab,Hematology,Platelets

Item

Peripheral Platelet Count (1000/uL or x 10 9/L)

float

Units

Item

Lab Unit of Measure (circle unit used)

text

C1519795 (UMLS CUI-1)

CL.23

Code List

Lab Unit of Measure (circle unit used)

CL Item

Ul (uL)

CL Item

X10^9/l (10 9/L)

CL Item

U/l (U/L)

CL Item

Mg/dl (mg/dl)

CL Item

Umol/l (umol/L)

CL Item

Meq/l (mEq/L)

CL Item

Mmol/l (mmol/L)

CL Item

G/dl (g/dL)

CL Item

G/l (g/L)

RequiredBiochemistry14DaysIndicator

Item

Required biochemistry investigations done within 14 days prior to randomization, and greater than 8 days following surgical resection, including

text

SpecimenCollectionDate

Item

Specimen Collection Date (Biochemistry, yyyy mmm dd)

date

C1302413 (UMLS CUI-1)

Bilirubin

Item

Bilirubin (uL or 10 9/L)

float

C1278039 (UMLS CUI-1)

Lab,Hepatic,AlkalinePhosphatase

Item

Alkaline Phosphatase (U/L; * If alkaline phosphatase is greater than ULN but <= 2.5 X ULN, ultrasound or CT scan of abdomen and bone scan MUST be done prior to randomization)

float

SGOT (AST)

Item

SGOT (AST) (U/L; ** If AST SGOT or ALT SGPT is greater than ULN but <= 2.5 X ULN, ultrasound, CT or MRI of abdomen MUST be done prior to randomization)

float

C0201899 (UMLS CUI-1)

SGPT

Item

SGPT (ALT) (U/L; ** If AST SGOT or ALT SGPT is greater than ULN but <= 2.5 X ULN, ultrasound, CT or MRI of abdomen MUST be done prior to randomization)

float

C0201836 (UMLS CUI-1)

Creatinine

Item

Creatinine (mg/dl or umol/L)

float

C0201976 (UMLS CUI-1)

HepaticBilirubinLabUpperLimitNormalValue

Item

Bilirubin ULN

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property-2)
C0005437 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-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)

SGOTLabUpperLimitNormalValue

Item

SGOT (AST) ULN

float

C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

SGPTLabUpperLimitNormalValue

Item

SGPT (ALT) ULN

float

C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)

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)

Adult

Item

Patient's age is >= 18 years (lower age limit subject to local policy regarding age at which patient may sign own consent)

boolean

C38147 (NCI Thesaurus ValueDomain)
C0001675 (UMLS CUI-1)

PrestudyChestX-RayIndicator

Item

Patient has had a chest x-ray within 14 days of randomization.

text

ChestX-RayAssessmentDate

Item

Date of chest x-ray (yyyy mmm dd)

date

PrestudyChestCTIndicator

Item

Patient has had a CT or MRI scan of the chest within 42 days prior to surgery.

text

Date CT or MR chest

Item

Date of CT or MRI of chest

date

C16502 (NCI Thesaurus ObjectClass)
C17204 (NCI Thesaurus ObjectClass-2)
C25389 (NCI Thesaurus ObjectClass-3)
C16809 (NCI Thesaurus ObjectClass-4)
C38000 (NCI Thesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS CUI-1)
C0040405 (UMLS CUI-2)
C0024485 (UMLS CUI-3)
C0817096 (UMLS CUI-4)

PrestudyEKGIndicator

Item

Patient has had an EKG within 14 days prior to randomization.

text

DiagnosticElectrocardiogramPerformedDate

Item

Date of EKG (yyyy mmm dd)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25482 (NCI Thesaurus ObjectClass)
C0348026 (UMLS 2011AA ObjectClass)
C0013798 (NCI Metathesaurus ObjectClass)

EligibilityContraceptionIndicator

Item

Men and women of childbearing age will use adequate contraception.

text

PrestudyPostoperativeRadiationTherapyIndicator

Item

Patient has received post-operative radiation. (If patient has received post-operative radiation therapy)

boolean

PrestudyRadiationTherapyCompleteIndicator

Item

Radiation therapy has been completed at least three weeks prior to randomization

text

RadiationTherapyToxicityRecoveryIndicator

Item

The patient has recovered from all radiation therapy related toxicity

text

AdjuvantRTEndDate

Item

Date Adjuvant Radiation Therapy Ended (yyyy mmm dd)

date

PatientConsentSignedIndicator

Item

Informed consent has been signed and dated by patient.

text

InformedConsentDateSigned

Item

Date informed consent signed (yyyy mmm dd)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

Patient accessible for treatment and follow-up

Item

Patient accessible for treatment and follow-up.

boolean

C16960 (NCI Thesaurus ObjectClass)
C16033 (NCI Thesaurus Property)
C49236 (NCI Thesaurus Property-2)
C25171 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C0013893 (UMLS CUI-1)

TreatmentRequirementBeginIndicator

Item

Initiation of protocol therapy will begin within 10 working days of randomization.

text

NoOtherMalignancyIndicator

Item

No other prior or concurrent malignancies within the last 5 years, except as specified in protocol section 5.2.1.

text

NoCombinationLungCancerIndicator

Item

No combination of small cell and non-small cell carcinomas or a pulmonary carcinoid tumour.

text

OneDiscretePrimaryCancerIndicator

Item

No more than one discrete area of apparent primary cancer (even if within same lobe, T4, IIIB are ineligible)

text

NoOphthalmologicGastrointestinalDiseaseIndicator

Item

No clinically significant or untreated ophthalmologic or gastrointestinal conditions.

text

NoPathologicRiskConditionIndicator

Item

No active pathological condition that would render the protocol treatment dangerous. (see protocol section 5.2.5 )

text

NoPsychiatricImpairmentHistoryIndicator

Item

No history of psychiatric or neurological disorder that would make the obtainment of informed consent problematic, or that would limit compliance with study requirements.

text

FemalePatientNotPregnantIndicator

Item

Patient, if female, is not pregnant or breast feeding.

text

CL.15

Code List

Patient, if female, is not pregnant or breast feeding.

CL Item

Na (NA)

NoPriorLungChemotherapyIndicator

Item

No prior adjuvant or neoadjuvant chemotherapy or immunotherapy for NSCLC. (limited low dose preoperative radiation therapy or endobronchial brachytherapy or laser therapy for short term control of hemoptysis or lobar obstruction is permitted, however full dose, pre-operative radiotherapy of curative intent is cause for exclusion )

text

NoAgentAllergyHistoryIndicator

Item

No history of allergic reactions to compounds of similar chemical or biologic composition to IRESSA.

text

NoCYP3A4EnzymeMedicationsIndicator

Item

Patient does not take drugs which induce CYP3A4 enzymes, e.g., phenytoin, carbamazepine, barbiturates, rifampicin or St John's Wort.

text

AdequateSurgicalHealingIndicator

Item

Adequate healing from previous oncologic or other major surgery has occurred.

text

PostoperativeRadiotherapyStatus

Item

Post-operative radiotherapy

text

CL.14

Code List

Post-operative radiotherapy

CL Item

Given (Given)

CL Item

Not Given (Not given)

RANDOMIZATION

Item Group

Randomization

C0034656 (UMLS CUI-1)

RandomizationDate

Item

Randomization Date (yyyy mmm dd)

date

InvestigatorSignature

Item

Investigator Signature

text

C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)

InvestigatorSignatureDate

Item

Date of Investigator Signature (yyyy mmm dd)

date

PersonCompletingForm,LastName

Item

Person Completing Form, Last Name

text

PersonCompletingForm,FirstName

Item

Person Completing Form, First Name

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

FormCompletionDate,Original

Item

Form Completion Date, Original (yyyy mmm dd)

date

HISTORY AND PHYSICAL EXAM

Item Group

History And Physical Exam

AssessmentDate

Item

Date of evaluation (yyyy mmm dd)

date

PatientCurrentSmokerIndicator

Item

Is patient currently smoking?

text

CL.16

Code List

Is patient currently smoking?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PatientPreviousSmokerIndicator

Item

Has previously been a smoker?

text

CL.17

Code List

Has previously been a smoker?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PerformanceStatus

Item

Performance Status (check _ one)

text

CL.18

Code List

Performance Status (check _ one)

CL Item

0 (0 = Fully active, able to carry on all pre-disease performance without restriction (Karnofsky 90-100))

C0919414 (NCI Metathesaurus)

CL Item

1 (1 = Restricted in physically strenuous activity but ambulatory (K 70-80))

CL Item

2 (2 = Ambulatory and capable of all self-care but unable to carry out any work activities (K 50-60))

C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)

CL Item

3 (3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours (K 30-40))

CL Item

4 (4 = Completely disabled, cannot carry on any self-care. Totally confined to bed or chair (K 10-20))

PatientHeight

Item

Patient Height (cm)

float

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

PatientWeight

Item

Patient Weight (kg)

float

INVESTIGATIONS

Item Group

Investigations

DiagnosticImagingAnatomicSite

Item

Imaging Site

text

C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25421 (NCI Thesaurus Property-2)
C0002808 (UMLS 2011AA Property-2)

CL.19

Code List

Imaging Site

CL Item

Chest (Chest)

C25389 (NCI Thesaurus)
C0817096 (UMLS 2011AA)

CL Item

Brain (Brain)

C12439 (NCI Thesaurus)
C0006104 (UMLS 2011AA)

CL Item

Abdomen (Abdomen)

C12664 (NCI Thesaurus)
C0230168 (UMLS 2011AA)

CL Item

Bone (Bone)

C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)

CL Item

Cardiac (Cardiac)

C13306 (NCI Thesaurus)
C1522601 (UMLS 2011AA)

AssessmentType

Item

Method of Evaluation

text

CL.20

Code List

Method of Evaluation

CL Item

Chest X-ray (Chest x-ray)

CL Item

Ct Scan (CT Scan)

CL Item

Mri (MRI (NMR))

CL Item

Ultrasound (Ultrasound)

C64384 (NCI Thesaurus)
C1456803 (UMLS 2011AA)

CL Item

Bone Scan (Bone scan)

C17646 (NCI Thesaurus)
C0203668 (UMLS 2011AA)

CL Item

Ekg (EKG)

CL Item

Not Evaluated (Not evaluated)

PregnancyTestResult

Item

Pregnancy test

text

CL.21

Code List

Pregnancy test

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Not Evaluated (Not evaluated)

HEMATOLOGY and BIOCHEMISTRY (baseline)

Item Group

Baseline Hematology/biochemistry Values

Lab,Hematology,Hemoglobin

Item

Hemoglobin (g/dl or g/L)

float

Lab,Hematology,Neutrophils,CellPercentage

Item

Peripheral Neutrophils (%)

float

Lab,Chemistry,LactateDehydrogenase

Item

Lactate Dehydrogenase (LDH) (U/L)

float

Lab,Chemistry,LactateDehydrogenase,ULN

Item

Lactate Dehydrogenase ULN

float

Lab,Renal,BUN

Item

BUN (mg/dl or umol/L)

float

BUN ULN

Item

BUN ULN

float

C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C61019 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0005845 (UMLS CUI-1)
C1519815 (UMLS CUI-2)

Lab,Electrolytes,Potassium

Item

Potassium (K) (mEq/L)

float

Potassium LLN

Item

Potassium LLN

float

C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C464 (NCI Thesaurus Property-2)
C765 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C0032821 (UMLS CUI-1)
C1518030 (UMLS CUI-2)

Potassium ULN

Item

Potassium ULN

float

C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C464 (NCI Thesaurus Property-2)
C765 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0032821 (UMLS CUI-1)
C1519815 (UMLS CUI-2)

Lab,Electrolytes,Sodium

Item

Sodium (Na) (mmol/L)

float

Sodium LLN

Item

Sodium LLN

float

C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C830 (NCI Thesaurus Property-2)
C464 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C0037473 (UMLS CUI-1)
C1518030 (UMLS CUI-2)

Sodium ULN

Item

Sodium ULN

float

C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C830 (NCI Thesaurus Property-2)
C464 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0037473 (UMLS CUI-1)
C1519815 (UMLS CUI-2)

Chloride

Item

Chloride (Cl)

float

C0201952 (UMLS CUI-1)

Chloride LLN

Item

Chloride LLN

float

C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C464 (NCI Thesaurus Property-2)
C1741 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C0201952 (UMLS CUI-1)
C1518030 (UMLS CUI-2)

Chloride ULN

Item

Chloride ULN

float

C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C464 (NCI Thesaurus Property-2)
C1741 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0201952 (UMLS CUI-1)
C1519815 (UMLS CUI-2)

Lab,Electrolytes,Calcium

Item

Calcium (Ca) (mg/dL or umol/L)

float

Calcium LLN

Item

Calcium LLN

float

C25294 (NCI Thesaurus ObjectClass)
C331 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C464 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C0006675 (UMLS CUI-1)
C1518030 (UMLS CUI-2)

Calcium ULN

Item

Calcium ULN

float

C25294 (NCI Thesaurus ObjectClass)
C331 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C464 (NCI Thesaurus Property-3)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0006675 (UMLS CUI-1)
C1519815 (UMLS CUI-2)

Chemistry,BloodAlbumin

Item

Albumin (g/dl or g/L)

float

Albumin LLN

Item

Albumin LLN

float

C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C214 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C0001924 (UMLS CUI-1)
C1518030 (UMLS CUI-2)

Albumin ULN

Item

Albumin ULN

float

C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C214 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C0001924 (UMLS CUI-1)
C1519815 (UMLS CUI-2)

DISEASE HISTORY and PRIOR TREATMENT

Item Group

Disease History/prior Treatment

PrimarySurgeryDate

Item

Primary Surgery Date (yyyy mmm dd)

date

NStage,Pathologic

Item

N Stage, Pathologic (check _ one)

text

CL.24

Code List

N Stage, Pathologic (check _ one)

CL Item

N0, According To Ajcc Criteria (N0)

CL Item

N1, According To Ajcc Criteria (N1)

CL Item

N2, According To Ajcc Criteria (N2)

CL Item

N3, According To Ajcc Criteria (N3)

CL Item

Nx, According To Ajcc Criteria (Nx)

TStage,Pathologic

Item

T Stage, Pathologic (check _ one)

text

CL.25

Code List

T Stage, Pathologic (check _ one)

CL Item

Tumor 2 Cm Or Less In Greatest Dimension (T1)

CL Item

Tumor More Than 2 Cm But Not More Than 5 Cm In Greatest Dimension (T2)

CL Item

Tumor More Than 5 Cm In Greatest Dimension (T3)

CL Item

Tumor Of Any Size With Direct (T4)

StageGrouping,Pathologic

Item

Stage Grouping, Pathologic

text

CL.26

Code List

Stage Grouping, Pathologic

CL Item

Ib, According To Current Ajcc Guidelines (IB)

CL Item

Iia, According To Current Ajcc Guidelines (IIA)

CL Item

Iib, According To Current Ajcc Guidelines (IIB)

CL Item

Iiia, According To Current Ajcc Guidelines (IIIA)

HistologicType,OtherName

Item

Specify other histologic type

text

HistologicGrade

Item

Histologic Grade (WHO)

text

CL.28

Code List

Histologic Grade (WHO)

CL Item

Well Differentiated (Grade I)

C14171 (NCI Thesaurus)
C0205615 (UMLS 2011AA)

CL Item

Moderate (Grade II)

CL Item

Poor (Grade III)

VascularInvasionInd

Item

Is there vascular invasion?

text

CL.29

Code List

Is there vascular invasion?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

ParietalPleuralMarginInvolvedInd

Item

Is the parietal pleural margin involved?

text

CL.30

Code List

Is the parietal pleural margin involved?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

LymphNodeSamplingInd

Item

Was lymph node sampling done?

text

CL.31

Code List

Was lymph node sampling done?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

LymphNode(s)ExaminedNumber

Item

Number of Lymph Nodes Examined (If yes,)

float

C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)

LymphNode(s)PositiveNumber

Item

Number of Positive Lymph Nodes

float

C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)

LymphNodesType

Item

Lymph Nodes Type (Station)

text

CL.32

Code List

Lymph Nodes Type (Station)

CL Item

Highest Mediastinal Node (Highest mediastinal (1))

CL Item

Right Upper Paratracheal Node (Right upper paratracheal (2R))

CL Item

Left Upper Paratracheal Node (Left upper paratracheal (2L))

CL Item

Pre- And Retro Paratracheal Node (Pre- and retro paratracheal (3))

CL Item

Right Lower Paratracheal Node (Right lower paratracheal (4R))

CL Item

Left Lower Paratracheal Node (Left lower paratracheal (4L))

CL Item

Subaortic Node (Subaortic (5))

CL Item

Para-aortic Node (Para-aortic (6))

CL Item

Subcarinal Node (Subcarinal (7))

CL Item

Paraesophageal (Paraesophageal (8))

C25344 (NCI Thesaurus)
C0475302 (UMLS 2011AA)

CL Item

Pulmonary Ligament (Pulmonary ligament (9))

C0225794 (NCI Metathesaurus)

CL Item

Right Hilar Node (Right hilar (10R))

CL Item

Left Hilar Node (Left hilar (10L))

CL Item

Interlobar Node (Interlobar (11))

CL Item

Right Lobar Node (Right lobar (12R))

CL Item

Left Lobar Node (Left lobar (12L))

CL Item

Right Segmental Node (Right segmental (13R))

CL Item

Left Segmental Node (Left segmental (13L))

CL Item

Right Subsegmental Node (Right subsegmental (14R))

CL Item

Left Subsegmental Node (Left subsegmental (14L))

LymphNodeInvolvement

Item

Lymph Node Involvement (* Indicate Node Involvement: 0= not evaluated; 3= pathologically positive; 4= pathologically negative; 5= equivocal; 6= unknown)

text

CL.33

Code List

Lymph Node Involvement (* Indicate Node Involvement: 0= not evaluated; 3= pathologically positive; 4= pathologically negative; 5= equivocal; 6= unknown)

CL Item

Not Evaluated (not evaluated)

CL Item

The Node Is Considered To Be Positive Based Upon Histological Evaluation. (pathologically positive)

CL Item

The Node Is Considered To Be Negative Based Upon Histological Evaluation. (pathologically negative)

CL Item

Equivocal (equivocal)

C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)

CL Item

Unknown (unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

SurgicalProcedureType

Item

Type of Procedure

text

CL.34

Code List

Type of Procedure

CL Item

Lobectomy (Lobectomy)

C15272 (NCI Thesaurus)
C0023928 (UMLS 2011AA)

CL Item

Pneumonectomy (Pneumonectomy)

C15305 (NCI Thesaurus)
C0032284 (UMLS 2011AA)

CL Item

Bilobectomy (Bilobectomy)

CL Item

Bronchial Sleeve Resection (Bronchial sleeve resection)

TumorSize,MaximumDiameter

Item

Tumour Size, Maximum Diameter (cm Record longest or largest diameter of tumour.)

float

TumorLocation,Side

Item

Tumour Location, Side

text

CL.35

Code List

Tumour Location, Side

CL Item

Left (Left)

C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)

CL Item

Right (Right)

C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)

TumorLocation,Area

Item

Tumour Location, Area (check _ all that apply)

text

CL.36

Code List

Tumour Location, Area (check _ all that apply)

CL Item

Upper Lobe (Upper lobe)

CL Item

Middle Lobe (Middle lobe)

CL Item

Lower Lobe (Lower lobe)

CL Item

Mainstem Bronchus (Mainstem bronchus)

CL Item

Carina (Carina)

C25264 (NCI Thesaurus)
C0225594 (UMLS 2011AA)

CL Item

Other, Specify (Other, specify)

TumorLocation,AreaOther

Item

Other, specify

text

TumorLocation,Zone

Item

Tumour Location, Zone (check _ all that apply)

text

CL.37

Code List

Tumour Location, Zone (check _ all that apply)

CL Item

Predominantly Central (Predominantly central)

CL Item

Predominantly Peripheral (Predominantly peripheral)

CL Item

Indeterminate (Indeterminate)

C48658 (NCI Thesaurus)
C0205258 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PleuraInvolvedInd

Item

Does the tumour involve the pleura?

text

CL.38

Code List

Does the tumour involve the pleura?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

TumorMarginInd

Item

Is the tumour at the surgical margin?

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25563 (NCI Thesaurus Property)
C0205284 (UMLS 2011AA Property)

CL.39

Code List

Is the tumour at the surgical margin?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

TumorExtension

Item

Tumour Extension (check _ all that apply)

text

CL.40

Code List

Tumour Extension (check _ all that apply)

CL Item

Chest Wall (Chest Wall)

CL035093 (NCI Metathesaurus)
C62484 (NCI Thesaurus)
C0205076 (UMLS 2011AA)

CL Item

Pericardium (Pericardium)

C13005 (NCI Thesaurus)
C0031050 (UMLS 2011AA)

CL Item

Mediastinum (Mediastinum)

C12748 (NCI Thesaurus)
C0025066 (UMLS 2011AA)

CL Item

Diaphragm (Diaphragm)

C12702 (NCI Thesaurus)
C0011980 (UMLS 2011AA)

CL Item

Esophagus (Esophagus)

C12389 (NCI Thesaurus)
C0014876 (UMLS 2011AA)

CL Item

Other, Specify (Other, specify)

TumorExtension,OtherStructures

Item

Other, specify

text

PriorAdjuvantRTInd

Item

Prior adjuvant RT? (If yes, record below)

text

CL.41

Code List

Prior adjuvant RT? (If yes, record below)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

AdjuvantRTBeginDate

Item

Date Adjuvant Radiation Therapy Started (yyyy mmm dd)

date

RTTotalDose

Item

Total dose of Radiation Therapy (cGy)

float

PriorAdjuvantChemotherapyInd

Item

Prior Adjuvant Chemotherapy?

text

CL.42

Code List

Prior Adjuvant Chemotherapy?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Adverse event

Item Group

Adverse event

C0877248 (UMLS CUI-1)

CTCAdverseEventTerm

Item

CTC Adverse Event Term (* Code/grade according to NCI Common Toxicity Criteria, version 2.0; Include all symptoms/findings including disease related symptoms present at baseline. All symptoms listed here must be reported on subsequent forms.)

text

C1516728 (UMLS CUI-1)
C2826934 (UMLS CUI-2)

CL.43

Code List

CL Item

Anorexia (anorexia)

CL Item

Chest Pain (chest pain (non-cardiac and non-pleuritic))

CL Item

Constipation (constipation)

CL Item

Diarrhea For Patients Without Colostomy (diarrhea (patients without colostomy))

CL Item

Dry Skin (dry skin)

CL Item

Dyspnea (dyspnea (shortness of breath))

CL Item

Fatigue (fatigue (lethargy, malaise, asthenia))

CL Item

Infection Without Neutropenia (infection (without neutropenia))

CL Item

Nausea (nausea)

CL Item

Pruritus (pruritus)

CL Item

Rash/desquamation (rash / desquamation)

CL Item

Vomiting (vomiting)

CTCAdverseEventTerm,Other

Item

CTC Adverse Event Term, Other

text

CTCAdverseEventCategory

Item

CTG Adverse Event Category (* Code/grade according to NCI Common Toxicity Criteria, Version 2.0)

text

CL.44

Code List

CTG Adverse Event Category (* Code/grade according to NCI Common Toxicity Criteria, Version 2.0)

CL Item

Gastrointestinal (Gastrointestinal)

CL Item

Pain (Pain)

CL Item

Dermatology/skin (Dermatology/Skin)

CL Item

Pulmonary (Pulmonary)

CL Item

Constitutional Symptoms (Constitutional Symptoms)

CL Item

Infection (Infection)

CTCAdverseEventGrade

Item

CTC Adverse Event Grade (0=None NA=Not Assessed; * Code/grade according to NCI Common Toxicity Criteria, Version 2.0)

text

C2985911 (UMLS CUI-1)

Comments

Item

COMMENTS

text

CONCOMITANT MEDICATIONS

Item Group

Concomitant Medications

C2347852 (UMLS CUI-1)

AgentName

Item

Agent Name (generic or trade name)

text

C0450442 (UMLS CUI-1)

ID

Descrição

Link

Palavras-chave

Versões (4)

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DOI

Licença

Comentários do modelo :

Comentários do grupo de itens para :

Comentários do item para :

NSCLC (NCT00049543)

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