ID

8511

Beschrijving

Lung Cancer - SCLC Extensive On-Study Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DE33769F-8545-3C96-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DE33769F-8545-3C96-E034-0003BA12F5E7

Trefwoorden

Versies (4)
  1. 2012-09-19 2012-09-19 -
  2. 2015-01-09 2015-01-09 - Martin Dugas
  3. 2015-01-09 2015-01-09 - Martin Dugas
  4. 2021-09-17 2021-09-17 -
Geüploaded op

9 januari 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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On-Study - Lung Cancer - SCLC Extensive On-Study Form - 2262596v3.0

Engels

No Instruction available.

1 Formulieren  
  1. StudyEvent: Lung Cancer - SCLC Extensive On-Study Form
    1. No Instruction available.
Crf Header
Beschrijving

Crf Header

Coordinating Group Protocol No.
Beschrijving

Protocol ID Coordinating Group

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1711341
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Coordinating Group Code
Beschrijving

Coordinating Group Code

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS CUI-1
C1711341
NCI Thesaurus ObjectClass
C17005
UMLS CUI-2
C0805701
NCI Thesaurus ObjectClass-2
C25462
NCI Thesaurus Property
C25364
Protocol Title
Beschrijving

Protocol Title

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986303
NCI Thesaurus ObjectClass
C25320
NCI Thesaurus Property
C42774
Patient Study ID
Beschrijving

Patient Study ID

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Institution/Affiliate
Beschrijving

Institution Name

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Other Patient ID
Beschrijving

Trial subject ID Participating Group

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Code
Beschrijving

ParticipatingGroupIdentifierCode

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C25608
UMLS 2011AA ObjectClass
C0679823
NCI Thesaurus ObjectClass-2
C17005
UMLS 2011AA ObjectClass-2
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Patient Name (initials acceptable)
Beschrijving

Patient Name

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1299487
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25364
Lung: Pre-treatment Characteristics
Beschrijving

Lung: Pre-treatment Characteristics

Patient Height (cm)
Beschrijving

Patient Height

Datatype

float

Maateenheden
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0489786
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
cm
Patient Weight (kg)
Beschrijving

Patient Weight

Datatype

float

Maateenheden
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Body Surface Area (m^2)
Beschrijving

Body Surface Area

Datatype

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005902
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
Performance Status (check one)
Beschrijving

ECOG Performance Status

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Weight loss in previous six months (check one)
Beschrijving

Weight Loss past six months

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C0043096
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C3828652
NCI Thesaurus Property
C3445
NCI Thesaurus ValueDomain-2
C25613
Lung: Disease Description - Sclc
Beschrijving

Lung: Disease Description - Sclc

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

Measurable Disease

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1513041
NCI Thesaurus Property
C25626
NCI Thesaurus ObjectClass
C2991
NCI Thesaurus ObjectClass-2
C37894
Is non-measurable disease present? (only applicable in studies where there is residual disease at baseline)
Beschrijving

Non-Measurable Disease

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1334988
NCI Thesaurus Property
C25626
NCI Thesaurus ObjectClass
C2991
NCI Thesaurus ObjectClass-2
C25589
Degree of Involvement of Metastatic Sites (to be included only if needed for stratification factor verification)
Beschrijving

MalignantNeoplasmMetastaticInvolvementType

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C14174
UMLS 2011AA Property
C0036525
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property-2
C25548
UMLS 2011AA Property-2
C1314939
Is pleural effusion present?
Beschrijving

Pleural Effusion

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0032227
NCI Thesaurus ObjectClass
C12468
NCI Thesaurus Property
C3003
NCI Thesaurus Property-2
C25223
Is it Malignant? (If yes,)
Beschrijving

Malignant Pleural Effusion

Datatype

text

Alias
NCI Thesaurus ObjectClass
C12468
UMLS CUI-1
C0080032
NCI Thesaurus Property
C3003
NCI Thesaurus Property-2
C25223
NCI Thesaurus ValueDomain
C14143
NCI Metathesaurus ValueDomain
C0021212
Units used for labs
Beschrijving

AssessmentMeasurableLabType

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C20989
UMLS 2011AA ObjectClass
C0031809
NCI Thesaurus Property
C37984
UMLS 2011AA Property
C0022877
NCI Thesaurus Property-2
C37894
UMLS 2011AA Property-2
C1513040
Albumin (g/dl)
Beschrijving

BloodSpecimenLaboratoryProcedureAlbuminValue

Datatype

float

Alias
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C214
UMLS 2011AA ValueDomain
C0001924
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
Hemoglobin (g/dl)
Beschrijving

Hemoglobin

Datatype

float

Maateenheden
  • g/dL
Alias
NCI Thesaurus Property
C16676
UMLS CUI-1
C0019046
NCI Thesaurus Property-2
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
g/dL
Lactate Dehydrogenase (LDH) (U/L only collect if RT study)
Beschrijving

LDH

Datatype

float

Maateenheden
  • U/L
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0202113
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property-2
C25184
U/L
Lactate Dehydrogenase ULN (U/L Provide laboratory's upper limit of normal)
Beschrijving

LDH ULN

Datatype

float

Maateenheden
  • U/L
Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0202113
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C25184
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C38024
NCI Thesaurus ValueDomain-3
C25706
U/L
Lung: Prior Treatment - Extensive Sclc
Beschrijving

Lung: Prior Treatment - Extensive Sclc

Prior Surgery (Code "No" if incisional/needle biopsy is the only prior surgery)
Beschrijving

Prior Surgery

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0744961
NCI Thesaurus Property
C38000
NCI Thesaurus ObjectClass
C15329
NCI Thesaurus ObjectClass-2
C25629
Prior Radiation Therapy
Beschrijving

Prior Radiation Therapy

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1522449
NCI Thesaurus ObjectClass
C15313
UMLS CUI-2
C0332152
NCI Thesaurus ObjectClass-2
C25629
NCI Thesaurus Property
C25382
Prior Systemic Chemotherapy
Beschrijving

PriorChemotherapyAdministeredInd-3

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Comments
Beschrijving

Comments

Comments
Beschrijving

Research Comments

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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No Instruction available.

1 Formulieren
  1. StudyEvent: Lung Cancer - SCLC Extensive On-Study Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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)
Patient Name
Item
Patient Name (initials acceptable)
text
C25191 (NCI Thesaurus ValueDomain)
C1299487 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
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)
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)
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)
Item Group
Lung: Disease Description - Sclc
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)
Item
Degree of Involvement of Metastatic Sites (to be included only if needed for stratification factor verification)
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property-2)
C1314939 (UMLS 2011AA Property-2)
CL.5
Code List
Degree of Involvement of Metastatic Sites (to be included only if needed for stratification factor verification)
CL Item
Single Lesion In Single Organ (Single lesion in single site or organ)
CL Item
Multiple Lesions In Single Organ (Multiple lesions in single site or organ)
CL Item
Multiple Lesions In Multiple Organs (Multiple lesions in multiple organs)
Pleural Effusion
Item
Is pleural effusion present?
boolean
C38148 (NCI Thesaurus ValueDomain)
C0032227 (UMLS CUI-1)
C12468 (NCI Thesaurus ObjectClass)
C3003 (NCI Thesaurus Property)
C25223 (NCI Thesaurus Property-2)
Item
Is it Malignant? (If yes,)
text
C12468 (NCI Thesaurus ObjectClass)
C0080032 (UMLS CUI-1)
C3003 (NCI Thesaurus Property)
C25223 (NCI Thesaurus Property-2)
C14143 (NCI Thesaurus ValueDomain)
C0021212 (NCI Metathesaurus ValueDomain)
CL.7
Code List
Is it Malignant? (If yes,)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown (not tapped))
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
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.8
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)
Hemoglobin
Item
Hemoglobin (g/dl)
float
C16676 (NCI Thesaurus Property)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
LDH
Item
Lactate Dehydrogenase (LDH) (U/L only collect if RT study)
float
C20200 (NCI Thesaurus Property)
C0202113 (UMLS CUI-1)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C25184 (NCI Thesaurus Property-2)
LDH ULN
Item
Lactate Dehydrogenase ULN (U/L Provide laboratory's upper limit of normal)
float
C25294 (NCI Thesaurus ObjectClass)
C0202113 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C25184 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C38024 (NCI Thesaurus ValueDomain-2)
C25706 (NCI Thesaurus ValueDomain-3)
Item Group
Lung: Prior Treatment - Extensive Sclc
Prior Surgery
Item
Prior Surgery (Code "No" if incisional/needle biopsy is the only prior surgery)
boolean
C38148 (NCI Thesaurus ValueDomain)
C0744961 (UMLS CUI-1)
C38000 (NCI Thesaurus Property)
C15329 (NCI Thesaurus ObjectClass)
C25629 (NCI Thesaurus ObjectClass-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)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
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