ID

10091

Beschreibung

E5204 Non-Protocol Therapy Form Combination Chemotherapy With or Without Bevacizumab in Treating Patients Who Have Had Surgery for Stage II or Stage III Rectal Cancer NCT00303628 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=089B4967-A7D1-3905-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=089B4967-A7D1-3905-E044-0003BA3F9857

Stichworte

Versionen (3)
  1. 27.08.12 27.08.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
  3. 25.03.15 25.03.15 - Martin Dugas
Hochgeladen am

25. März 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy
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Colorectal Cancer Non-Protocol Therapy NCT00303628

Englisch

INSTRUCTIONS: Use this form to capture the first occurrence of non-protocol anti-tumor therapy per registration step

1 Formulare  
Header
Beschreibung

Header

Alias
UMLS CUI-1
C1320722
ECOG Protocol Number
Beschreibung

Protocol Number ECOG

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Beschreibung

Patient ID ECOG

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
DCI Name
Beschreibung

Generic drug form

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C3242750
NCI Thesaurus Property
C19464
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus ObjectClass-2
C25452
Registration Step
Beschreibung

Registration Number

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Reporting Period
Beschreibung

Clinical Trial Period

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2347804
NCI Thesaurus ObjectClass
C25214
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass-2
C25651
Patient Initials (Last, First)
Beschreibung

Patient Initials

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Participating Group Protocol Number
Beschreibung

Study Number Participating Group

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Institution/Affiliate
Beschreibung

Institution Name

Datentyp

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
Participating Group Patient ID
Beschreibung

Trial subject ID Participating Group

Datentyp

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

Data amended

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date data amended (s - mm/dd/yyyy)
Beschreibung

Data amended date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25416
NCI Thesaurus ValueDomain-2
C25367
Investigator Signature
Beschreibung

Investigator Signature

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
Investigator Signature Date
Beschreibung

Investigator Signature Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
Non-protocol Therapy
Beschreibung

Non-protocol Therapy

Alias
UMLS CUI-1
C1518384
Date of First Non-Protocol Therapy
Beschreibung

Non-ProtocolTherapyFirstAdministeredDate Date of First Non-Protocol Therapy (if given prior to progression/relapse from protocol therapy)

Datentyp

date

Maßeinheiten
  • mm/dd/yyyy
Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
NCI Thesaurus Property
C25509
NCI Thesaurus Property-2
C25382
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
UMLS CUI-1
C1518384
UMLS CUI-2
C3173309
mm/dd/yyyy
Non-protocol Chemotherapy
Beschreibung

Non-protocolChemotherapyAdministeredInd-3

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus ObjectClass
C15632
NCI Thesaurus ObjectClass-2
C25590
NCI Thesaurus Property
C25382
UMLS CUI-1
C0392920
UMLS CUI-2
C1518384
Non-protocol Hormonal Therapy
Beschreibung

Non-protocolHormonalTherapyAdministeredInd-3

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus ObjectClass
C15445
NCI Thesaurus ObjectClass-2
C25590
NCI Thesaurus Property
C25382
UMLS CUI-1
C0279025
UMLS CUI-2
C1518384
Non-protocol Immunotherapy (Biological Response Modifiers)
Beschreibung

Non-ProtocolImmunotherapyAdministeredInd-3

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus ObjectClass
C15262
NCI Thesaurus ObjectClass-2
C25590
NCI Thesaurus Property
C25382
UMLS CUI-1
C0021083
UMLS CUI-2
C1518384
Non-protocol High Dose Chemotherapy/Stem Cell Transplant (Autologous or Allogeneic)
Beschreibung

Non-protocolChemotherapyTransplantAdministeredInd-3

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C15632
NCI Thesaurus ObjectClass-2
C25590
NCI Thesaurus Property
C12981
NCI Thesaurus Property-2
C25382
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0392920
UMLS CUI-2
C0332835
UMLS CUI-3
C1518384
Non-protocol Surgery
Beschreibung

Non-protocolSurgeryPerformedInd-3

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus Property
C38000
NCI Thesaurus ObjectClass
C15329
NCI Thesaurus ObjectClass-2
C25590
UMLS CUI-1
C0543467
UMLS CUI-2
C1518384
Non-protocol surgery type
Beschreibung

Non-ProtocolSurgeryProcedureText

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ObjectClass
C15329
NCI Thesaurus Property
C15368
NCI Thesaurus ObjectClass-2
C25590
UMLS CUI-1
C0543467
UMLS CUI-2
C1518384
Non-protocol Radiation Therapy
Beschreibung

Non-protocolRadiationTherapyAdministeredInd-3

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus ObjectClass
C15313
NCI Thesaurus ObjectClass-2
C25590
NCI Thesaurus Property
C25382
UMLS CUI-1
C1522449
UMLS CUI-2
C1518384
Non-protocol RT type
Beschreibung

Non-ProtocolRTAdministeredText

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ObjectClass
C15313
NCI Thesaurus ObjectClass-2
C25590
NCI Thesaurus Property
C25382
UMLS CUI-1
C1522449
UMLS CUI-2
C1518384
Other Non-protocol Therapy
Beschreibung

Non-protocolTherapyOtherAdministeredInd-3

Datentyp

boolean

Alias
NCI Thesaurus Property
C17649
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
NCI Thesaurus Property-2
C25382
UMLS CUI-1
C0205394
UMLS CUI-2
C1518384
Name of other non-protocol therapy
Beschreibung

Non-protocolTherapyOtherAdministeredName

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25590
NCI Thesaurus Property
C17649
NCI Thesaurus Property-2
C25382
NCI Thesaurus ValueDomain
C42614
UMLS CUI-1
C1518384
UMLS CUI-2
C0205394
Was the non-protocol therapy given for the disease of this protocol
Beschreibung

ProtocolDiseaseNon-protocolTherapyInd-3 Was the non-protocol therapy given for the disease of this protocol (NOTE: Treatment for a second primary in the same organ site would not be considered therapy for disease of this protocol.)

Datentyp

boolean

Alias
NCI Thesaurus ObjectClass
C2991
NCI Thesaurus ObjectClass-2
C42651
NCI Thesaurus Property
C15368
NCI Thesaurus Property-2
C25590
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0012634
UMLS CUI-2
C1518384
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Ähnliche Modelle

INSTRUCTIONS: Use this form to capture the first occurrence of non-protocol anti-tumor therapy per registration step

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
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)
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
Non-protocol Therapy (Non-Protocol Therapy)
Patient Initials
Item
Patient Initials (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
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)
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
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)
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 (s - mm/dd/yyyy)
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)
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)
Item Group
Non-protocol Therapy
C1518384 (UMLS CUI-1)
Non-Protocol Therapy Begin Date
Item
Date of First Non-Protocol Therapy
date
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C25509 (NCI Thesaurus Property)
C25382 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C1518384 (UMLS CUI-1)
C3173309 (UMLS CUI-2)
Non-protocol Chemotherapy
Item
Non-protocol Chemotherapy
boolean
C38148 (NCI Thesaurus ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C0392920 (UMLS CUI-1)
C1518384 (UMLS CUI-2)
Non-protocol Hormonal Therapy
Item
Non-protocol Hormonal Therapy
boolean
C38148 (NCI Thesaurus ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C0279025 (UMLS CUI-1)
C1518384 (UMLS CUI-2)
Non-protocol Immunotherapy
Item
Non-protocol Immunotherapy (Biological Response Modifiers)
boolean
C38148 (NCI Thesaurus ValueDomain)
C15262 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C0021083 (UMLS CUI-1)
C1518384 (UMLS CUI-2)
Non-protocol High Dose Chemotherapy/Stem Cell Transplant
Item
Non-protocol High Dose Chemotherapy/Stem Cell Transplant (Autologous or Allogeneic)
boolean
C15632 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C12981 (NCI Thesaurus Property)
C25382 (NCI Thesaurus Property-2)
C38148 (NCI Thesaurus ValueDomain)
C0392920 (UMLS CUI-1)
C0332835 (UMLS CUI-2)
C1518384 (UMLS CUI-3)
Non-protocol Surgery
Item
Non-protocol Surgery
boolean
C38148 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C15329 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS CUI-1)
C1518384 (UMLS CUI-2)
Non-protocol surgery type
Item
Non-protocol surgery type
text
C25704 (NCI Thesaurus ValueDomain)
C15329 (NCI Thesaurus ObjectClass)
C15368 (NCI Thesaurus Property)
C25590 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS CUI-1)
C1518384 (UMLS CUI-2)
Non-protocol Radiation Therapy
Item
Non-protocol Radiation Therapy
boolean
C38148 (NCI Thesaurus ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1522449 (UMLS CUI-1)
C1518384 (UMLS CUI-2)
Non-protocol RT type
Item
Non-protocol RT type
text
C25704 (NCI Thesaurus ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1522449 (UMLS CUI-1)
C1518384 (UMLS CUI-2)
Other Non-protocol Therapy
Item
Other Non-protocol Therapy
boolean
C17649 (NCI Thesaurus Property)
C38148 (NCI Thesaurus ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property-2)
C0205394 (UMLS CUI-1)
C1518384 (UMLS CUI-2)
Name of other non-protocol therapy
Item
Name of other non-protocol therapy
text
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C17649 (NCI Thesaurus Property)
C25382 (NCI Thesaurus Property-2)
C42614 (NCI Thesaurus ValueDomain)
C1518384 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
non-protocol therapy given for the disease of this protocol
Item
Was the non-protocol therapy given for the disease of this protocol
boolean
C2991 (NCI Thesaurus ObjectClass)
C42651 (NCI Thesaurus ObjectClass-2)
C15368 (NCI Thesaurus Property)
C25590 (NCI Thesaurus Property-2)
C38148 (NCI Thesaurus ValueDomain)
C0012634 (UMLS CUI-1)
C1518384 (UMLS CUI-2)
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