ID

10420

Beschrijving

On-Study Form Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A670D091-E97C-4BF1-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A670D091-E97C-4BF1-E034-0003BA0B1A09

Trefwoorden

  1. 19-09-12 19-09-12 -
  2. 01-06-15 01-06-15 -
  3. 03-06-15 03-06-15 -
  4. 20-09-21 20-09-21 -
Geüploaded op

1 juni 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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On-Study Form

No Instruction available.

  1. StudyEvent: On-Study Form
    1. No Instruction available.
ECOG clinical trial administrative data
Beschrijving

ECOG clinical trial administrative data

ECOG Protocol No.
Beschrijving

ECOGProtocolNo.

Datatype

text

ECOG Patient ID
Beschrijving

ECOGPatientID

Datatype

text

Registration Step
Beschrijving

RegistrationStep

Datatype

text

Patient?s Name
Beschrijving

Patient'sName

Datatype

text

Participating Group Protocol No.
Beschrijving

ParticipatingGroupProtocolNo.

Datatype

text

Participating Group Patient ID
Beschrijving

ParticipatingGroupPatientID

Datatype

text

Institution/Affiliate
Beschrijving

MainMemberInstitution/Affiliate

Datatype

text

Are data amended?
Beschrijving

AmendedDataInd

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Vital status
Beschrijving

Vital status

Performance status
Beschrijving

PerformanceStatus

Datatype

text

Weight loss in previous 6 months (choose one)
Beschrijving

WeightLossPriorSixMonths

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3445
UMLS 2011AA Property
C0043096
Anatomic Description Of Disease
Beschrijving

Anatomic Description Of Disease

Date of initial diagnosis of primary tumor (first positive biopsy date)
Beschrijving

FirstPositiveBiopsyDate

Datatype

date

Primary site (choose one)
Beschrijving

PrimarySite

Datatype

text

Other specify (primary site)
Beschrijving

PrimarySite,Other

Datatype

text

Histologic Type (choose one)
Beschrijving

HistologicType

Datatype

text

Other, specify (histologic type)
Beschrijving

HistologicType,OtherName

Datatype

text

Histologic grade (choose one)
Beschrijving

HistologicGrade

Datatype

text

Staging
Beschrijving

Staging

Clinical T Stage
Beschrijving

TStage,Clinical

Datatype

text

Clinical N Stage
Beschrijving

NStage,Clinical

Datatype

text

Clinical M Stage
Beschrijving

MStage,Clinical

Datatype

text

Site(s) Of Involvement
Beschrijving

Site(s) Of Involvement

Primary tumor/Pancreas
Beschrijving

Primarytumor/Pancreas

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain-2
C25180
UMLS 2011AA ValueDomain-2
C1522602
Regional lymph nodes
Beschrijving

RegionalLymphNode(s)Ind

Datatype

text

Distant lymph nodes
Beschrijving

DistantLymphNode(s)Ind

Datatype

text

Adjacent viscera/vessels
Beschrijving

Adjacentviscera/vessels

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain-2
C25180
UMLS 2011AA ValueDomain-2
C1522602
Liver
Beschrijving

LiverSiteInd

Datatype

text

Peritoneum
Beschrijving

PeritoneumInd

Datatype

text

Lung
Beschrijving

LungSiteInd

Datatype

text

Bone
Beschrijving

BoneSiteInd

Datatype

text

Other
Beschrijving

OtherSiteInd

Datatype

boolean

Specify other disease involvement
Beschrijving

OtherSiteName

Datatype

text

Comments
Beschrijving

Comments

Datatype

text

Investigator Signature
Beschrijving

InvestigatorSignature

Datatype

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Date
Beschrijving

InvestigatorSignatureDate

Datatype

date

Ccrr Module For On-study Form
Beschrijving

Ccrr Module For On-study Form

Other, specify
Beschrijving

DiseaseInvolvementSite,Other

Datatype

text

Similar models

No Instruction available.

  1. StudyEvent: On-Study Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
ECOG clinical trial administrative data
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGPatientID
Item
ECOG Patient ID
text
RegistrationStep
Item
Registration Step
text
Patient'sName
Item
Patient?s Name
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
ParticipatingGroupPatientID
Item
Participating Group Patient ID
text
MainMemberInstitution/Affiliate
Item
Institution/Affiliate
text
AmendedDataInd
Item
Are data amended?
boolean
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Item Group
Vital status
Item
Performance status
text
Code List
Performance status
CL Item
0 (Fully active, able to carry on all pre-disease performance without restriction (Karnofsky 90-100))
C0919414 (NCI Metathesaurus)
CL Item
1 (Restricted in physically strenuous activity but ambulatory (K 70-80))
CL Item
2 (Ambulatory and capable of all selfcare but unable to carry out any work activities (K 50-60))
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours (K 30-40))
CL Item
4 (completely disabled (K 10-20))
Item
Weight loss in previous 6 months (choose one)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3445 (NCI Thesaurus Property)
C0043096 (UMLS 2011AA Property)
Code List
Weight loss in previous 6 months (choose one)
CL Item
<5% Of Body Weight (less than 5% of body weight)
CL Item
5 To <10% Of Body Weight (5 - <10% of body weight)
CL Item
10 To <20% Of Body Weight (10 - <20% of body weight)
CL Item
> Or = 20% Of Body Weight (greater than or equal to 20% of body weight)
Item Group
Anatomic Description Of Disease
FirstPositiveBiopsyDate
Item
Date of initial diagnosis of primary tumor (first positive biopsy date)
date
Item
Primary site (choose one)
text
Code List
Primary site (choose one)
CL Item
Head Of Pancreas (Head of pancreas)
C0227579 (NCI Metathesaurus)
CL Item
Body Of Pancreas (Body of pancreas)
C0227582 (NCI Metathesaurus)
CL Item
Tail Of Pancreas (Tail of pancreas)
C0227590 (NCI Metathesaurus)
CL Item
Uncinate Process (Uncinate process)
CL Item
Diffuse (Diffuse)
C14175 (NCI Thesaurus)
C0205219 (UMLS 2011AA)
CL Item
Pancreas, Not Otherwise Specified (Pancreas, NOS)
CL Item
Other, Specify (Other, specify)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
PrimarySite,Other
Item
Other specify (primary site)
text
Item
Histologic Type (choose one)
text
Code List
Histologic Type (choose one)
CL Item
Ductal Adenocarcinoma (Ductal adenocarcinoma)
CL Item
Adenosquamous Carcinoma (Adenosquamous carcinoma)
C3727 (NCI Thesaurus)
C0206623 (UMLS 2011AA)
CL Item
Mucinous Adenocarcinoma (Mucinous adenocarcinoma)
C26712 (NCI Thesaurus)
C0007130 (UMLS 2011AA)
CL Item
Mucinous Noncystic Carcinoma (Mucinous noncystic carcinoma)
CL Item
Neuroendocrine Carcinoma (Neuroendocrine carcinoma)
C3773 (NCI Thesaurus)
C0206695 (UMLS 2011AA)
CL Item
Acinar Cell Carcinoma (Acinar cell carcinoma)
C3768 (NCI Thesaurus)
C0206685 (UMLS 2011AA)
CL Item
Mixed-type (ductal-endocrine Or Acinar-endocrine) (Mixed type (ductal-endocrine or acinar-endocrine)
CL Item
Signet Ring Cell Carcinoma (Signet ring cell carcinoma)
C3774 (NCI Thesaurus)
C0206696 (UMLS 2011AA)
CL Item
Small Cell Carcinoma (Small cell carcinoma)
C3915 (NCI Thesaurus)
C0262584 (UMLS 2011AA)
CL Item
Undifferentiated (anaplastic) Carcinoma (Undifferentiated (anaplastic) carcinoma)
CL Item
Other, Specify (Other, specify)
HistologicType,OtherName
Item
Other, specify (histologic type)
text
Item
Histologic grade (choose one)
text
Code List
Histologic grade (choose one)
CL Item
Tumor Is Well Differentiated According To Who Grading System (Well differentiated)
CL Item
Tumor Is Moderately Differentiated According To Who Grading System (Moderately differentiated)
CL Item
Tumor Is Poorly Differentiated According To Who Grading System (Poorly differentiated)
CL Item
Tumor Is Undifferentiated According To Who Grading System (Undifferentiated)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
Staging
Item
Clinical T Stage
text
Code List
Clinical T Stage
CL Item
T0, According To Ajcc Criteria (0)
CL Item
T1, According To Ajcc Criteria (1)
CL Item
T2, According To Ajcc Criteria (2)
CL Item
T3, According To Ajcc Criteria (3)
CL Item
T4, According To Ajcc Criteria (4)
CL Item
Tx, According To Ajcc Criteria (X)
Item
Clinical N Stage
text
Code List
Clinical N Stage
CL Item
No Lymph Node Involvement According To Ajcc Guidelines (0)
CL Item
N1, According To Ajcc Criteria (1)
CL Item
Lymph Node Involvement Cannot Be Assessed According To Ajcc Guidelines (use For Esophageal, Gastric, And Pancreatic) (X)
Item
Clinical M Stage
text
Code List
Clinical M Stage
CL Item
No Distant Metastases According To Ajcc Guidelines (0)
CL Item
Distant Metastases Present According To Ajcc Guidelines (1)
CL Item
Distant Metastases Presence Or Absence Cannot Be Assessed According To Ajcc Guidelines (X)
Item Group
Site(s) Of Involvement
Item
Primary tumor/Pancreas
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25180 (NCI Thesaurus ValueDomain-2)
C1522602 (UMLS 2011AA ValueDomain-2)
Code List
Primary tumor/Pancreas
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)
Item
Regional lymph nodes
text
Code List
Regional lymph nodes
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)
Item
Distant lymph nodes
text
Code List
Distant lymph nodes
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)
Item
Adjacent viscera/vessels
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25180 (NCI Thesaurus ValueDomain-2)
C1522602 (UMLS 2011AA ValueDomain-2)
Code List
Adjacent viscera/vessels
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)
Item
Liver
text
Code List
Liver
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)
Item
Peritoneum
text
Code List
Peritoneum
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)
Item
Lung
text
Code List
Lung
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)
Item
Bone
text
Code List
Bone
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)
OtherSiteInd
Item
Other
boolean
OtherSiteName
Item
Specify other disease involvement
text
Comments
Item
Comments
text
InvestigatorSignature
Item
Investigator Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Date
date
Item Group
Ccrr Module For On-study Form
DiseaseInvolvementSite,Other
Item
Other, specify
text

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