ID

7250

Beskrivning

(for Adjuvant Studies and Inoperable Stage III) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1518EC72-3397-4058-E044-0003BA3F9857

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1518EC72-3397-4058-E044-0003BA3F9857

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9 januari 2015

DOI

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On-Study - Lung Cancer - NSCLC Stage I-III On-Study Form - 2019422v3.0

model
Detaljer

No Instruction available.

1 Formulär

StudyEvent: Lung Cancer - NSCLC Stage I-III On-Study Form
1. No Instruction available.

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

CRF Header

Item Group

Crf Header

Protocol ID Coordinating Group

Item

Coordinating Group Protocol No.

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1711341 (UMLS CUI-2)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Coordinating Group Code

Item

Coordinating Group Code

text

C25162 (NCI Thesaurus ValueDomain)
C1711341 (UMLS CUI-1)
C17005 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25462 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)

Protocol Title

Item

Protocol Title

text

C25191 (NCI Thesaurus ValueDomain)
C2986303 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C42774 (NCI Thesaurus Property)

Patient Study ID

Item

Patient Study ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (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)

Trial subject ID Participating Group

Item

Other 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)

ParticipatingGroupIdentifierCode

Item

Participating Group Code

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C1257890 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PatientName

Item

Patient Name (initials acceptable)

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

Lung: Pre-Treatment Characteristics

Item Group

Lung: Pre-treatment Characteristics

Patient Height

Item

Patient Height (cm)

float

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

Patient Weight

Item

Patient Weight (kg)

float

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

Body Surface Area

Item

Body Surface Area (m^2)

float

C25209 (NCI Thesaurus ValueDomain)
C0005902 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)

ECOG Performance Status

Item

Performance Status (check one)

text

C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)

CL.1

Code List

Performance Status (check one)

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)

Weight Loss past six months

Item

Weight loss in previous six months (check one)

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.2

Code List

Weight loss in previous six months (check one)

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)

Lung: Disease Description - Stage I-III

Item Group

Lung: Disease Description - Stage I-iii

T Stage clinical

Item

T Stage, Clinical (leave blank if not done)

text

C3262 (NCI Thesaurus ObjectClass)
C0475455 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C0205210 (UMLS CUI-2)
C25398 (NCI Thesaurus Property)
C25728 (NCI Thesaurus Property-2)
C16899 (NCI Thesaurus ValueDomain)

CL.3

Code List

T Stage, Clinical (leave blank if not done)

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)

CL Item

No Evidence Of Primary Tumor (T0)

CL Item

Carcinoma In Situ (Tis)

C2917 (NCI Thesaurus)
C0007099 (UMLS 2011AA)

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

N Stage clinical

Item

N Stage, Clinical (leave blank if not done)

text

C3262 (NCI Thesaurus ObjectClass)
C0456532 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C0205210 (UMLS CUI-2)
C25398 (NCI Thesaurus Property)
C25580 (NCI Thesaurus Property-2)
C16899 (NCI Thesaurus ValueDomain)

CL.4

Code List

N Stage, Clinical (leave blank if not done)

CL Item

Regional Lymph Nodes Cannot Be Assessed (NX)

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)

M Stage clinical

Item

M Stage, Clinical (leave blank if not done)

text

C3262 (NCI Thesaurus ObjectClass)
C0456533 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C0205210 (UMLS CUI-2)
C25398 (NCI Thesaurus Property)
C25727 (NCI Thesaurus Property-2)
C16899 (NCI Thesaurus ValueDomain)

CL.5

Code List

M Stage, Clinical (leave blank if not done)

CL Item

Distant Metastasis Cannot Be Assessed (MX)

CL Item

No Distant Metastasis (M0)

CL Item

Distant Metastasis Present (M1)

T Stage pathologic

Item

T Stage, Pathologic (leave blank if not done)

text

C3262 (NCI Thesaurus ObjectClass)
C0475455 (UMLS CUI-1)
C16899 (NCI Thesaurus ValueDomain)
C1521733 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)

CL.6

Code List

T Stage, Pathologic (leave blank if not done)

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 (pTX)

CL Item

No Evidence Of Primary Tumor (pT0)

CL Item

Carcinoma In Situ (pTis)

C2917 (NCI Thesaurus)
C0007099 (UMLS 2011AA)
C2917 (NCI Thesaurus-3)
C0007099 (UMLS 2011AA-4)

CL Item

Tumor 3cm 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) (pT1)

CL Item

Tumor Of Any Size That Invades Any Of The Following: Mediastinum, Heart, Great Vessels, Trachea, Esophagus, Vertebral Body, Carina; Or Separate Tumor Nodules In The Same Lobe; Or Tumor With A Malignant Pleural Effusion (pT4)

N Stage pathologic

Item

N Stage, Pathologic (leave blank if not done)

text

C3262 (NCI Thesaurus ObjectClass)
C0456532 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C1521733 (UMLS CUI-2)
C25610 (NCI Thesaurus Property)
C25580 (NCI Thesaurus Property-2)
C16899 (NCI Thesaurus ValueDomain)

CL.7

Code List

N Stage, Pathologic (leave blank if not done)

CL Item

Regional Lymph Nodes Cannot Be Assessed (pNX)

CL Item

No Lymph Node Metastasis (pN0)

CL Item

Metastasis To Ipsilateral Peribronchial And/or Ipsilateral Hilar Lymph Nodes, And Intrapulmonary Nodes Including Involvement By Direct Extension Of The Primary Tumor (pN1)

CL Item

Metastasis To Ipsilateral Mediastinal And/or Subcarinal Lymph Node(s) (pN2)

CL Item

Metastasis To Contralateral Mediastinal, Contralateral Hilar, Ipsilateral Or Contralateral Scalene, Or Supraclavicular Lymph Node(s) (pN3)

M Stage pathologic

Item

M Stage, Pathologic (leave blank if not done)

text

C3262 (NCI Thesaurus ObjectClass)
C0456533 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C1521733 (UMLS CUI-2)
C25610 (NCI Thesaurus Property)
C25727 (NCI Thesaurus Property-2)
C16899 (NCI Thesaurus ValueDomain)

CL.8

Code List

M Stage, Pathologic (leave blank if not done)

CL Item

Distant Metastasis Cannot Be Assessed (pMX)

CL Item

No Distant Metastasis (pM0)

CL Item

Distant Metastasis Present (pM1)

Mediastinoscopy with biopsy

Item

Pathologic Stage based on Mediastinoscopy?

boolean

C19157 (NCI Thesaurus ObjectClass)
C0198422 (UMLS CUI-1)
C3200 (NCI Thesaurus ObjectClass-2)
C16829 (NCI Thesaurus Property)
C25452 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)

Bronchoscopy with biopsy

Item

Pathologic Stage based on Bronchoscopy?

boolean

C19157 (NCI Thesaurus ObjectClass)
C0189396 (UMLS CUI-1)
C3200 (NCI Thesaurus ObjectClass-2)
C16366 (NCI Thesaurus Property)
C25452 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)

Open biopsy of pleura

Item

Pathologic Stage based on Thoracotomy/Sternotomy?

boolean

C19157 (NCI Thesaurus ObjectClass)
C0189517 (UMLS CUI-1)
C3200 (NCI Thesaurus ObjectClass-2)
C15537 (NCI Thesaurus Property)
C25452 (NCI Thesaurus Property-2)
C38147 (NCI Thesaurus ValueDomain)

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.12

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 Undifferentiated (Large cell undifferentiated)

CL Item

Bronchoalveolar (bac) (Bronchoalveolar carcinoma (BAC))

CL Item

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

CL Item

Other (Other specify)

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

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)

Resection type primary tumor

Item

Status of Primary Tumor

text

C25284 (NCI Thesaurus ValueDomain)
C0449522 (UMLS CUI-1)
C3262 (NCI Thesaurus ObjectClass)
C0677930 (UMLS CUI-2)
C25251 (NCI Thesaurus ObjectClass-2)
C15232 (NCI Thesaurus Property)

CL.13

Code List

Status of Primary Tumor

CL Item

Unresected (Unresected)

CL Item

Not Recurrent, Resected, No Residual Tumor (Not recurrent, resected, no residual tumor)

CL Item

Not Recurrent, Resected, Residual Tumor (Not recurrent, resected, residual tumor)

CL Item

Recurrent (Recurrent)

C14173 (NCI Thesaurus)
C2945760 (UMLS 2011AA)

Measurable Disease

Item

Is measurable disease present? (only applicable in studies where there is residual disease at baseline)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1513041 (UMLS CUI-1)
C25626 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C37894 (NCI Thesaurus ObjectClass-2)

Non-Measurable Disease

Item

Is non-measurable disease present? (only applicable in studies where there is residual disease at baseline)

boolean

C38148 (NCI Thesaurus ValueDomain)
C1334988 (UMLS CUI-1)
C25626 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C25589 (NCI Thesaurus ObjectClass-2)

AssessmentMeasurableLabType

Item

Units used for labs

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C37894 (NCI Thesaurus Property-2)
C1513040 (UMLS 2011AA Property-2)

CL.16

Code List

Units used for labs

CL Item

Scientific/international (S/I)

CL Item

Imperial (Imperial)

BloodSpecimenLaboratoryProcedureAlbuminValue

Item

Albumin (g/dL)

float

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C214 (NCI Thesaurus ValueDomain)
C0001924 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)

LaboratoryProcedureHemoglobinResultSpecifiedValue

Item

Hemoglobin (g/dL)

float

C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureLactateDehydrogenaseResultSpecifiedValue

Item

Lactate Dehydrogenase (LDH) (only collect if RT study - U/L)

float

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25184 (NCI Thesaurus Property-2)
C0022917 (UMLS 2011AA Property-2)

LaboratoryProcedureLactateDehydrogenaseResultSpecifiedUpperLimitofNormalValue

Item

Lactate Dehydrogenase ULN (only collect if RT study - U/L - Provide laboratory's upper limit of normal)

float

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25184 (NCI Thesaurus Property-2)
C0022917 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C0205369 (UMLS 2011AA ValueDomain-2)
C25706 (NCI Thesaurus ValueDomain-3)
C1519815 (UMLS 2011AA ValueDomain-3)

Lung: Prior Treatment - NSCLC Stage I-III

Item Group

Lung: Prior Treatment - Nsclc Stage I-iii

Prior Surgery

Item

Prior Surgery

boolean

C38148 (NCI Thesaurus ValueDomain)
C0744961 (UMLS CUI-1)
C38000 (NCI Thesaurus Property)
C15329 (NCI Thesaurus ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)

Primary Surgery Type

Item

Primary Surgery Type

text

C25251 (NCI Thesaurus ObjectClass)
C0944781 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass-2)
C15329 (NCI Thesaurus ObjectClass-3)
C38000 (NCI Thesaurus Property)
C25284 (NCI Thesaurus ValueDomain)

CL.18

Code List

Primary Surgery Type

CL Item

Wedge Resection (Wedge Resection)

CL Item

Bilobectomy (Bilobectomy)

CL Item

Segmentectomy (Segmentectomy)

CL Item

Pneumonectomy (Pneumonectomy)

C15305 (NCI Thesaurus)
C0032284 (UMLS 2011AA)

CL Item

Sleeve Resection (Sleeve resection)

CL Item

Exploration, No Resection (Exploration, No Resection)

PrimarySurgeryDate

Item

Primary Surgery Date

date

C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

Prior Radiation Therapy

Item

Prior Radiation Therapy

boolean

C38148 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C0332152 (UMLS CUI-2)
C25629 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)

PriorChemotherapyAdministeredInd-3

Item

Prior Systemic Chemotherapy

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

Comments

Item Group

Allows Documentation Of Any Additional Cooments

Research Comments

Item

Comments (optional)

text

C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)

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On-Study - Lung Cancer - NSCLC Stage I-III On-Study Form - 2019422v3.0

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