ID

10792

Beschreibung

E3805 Prostate Follow-up PSA Assessment Form NCT00309985 Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F982C048-0203-4A00-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=F982C048-0203-4A00-E034-0003BA3F9857

Stichworte

Versionen (3)
  1. 19.09.12 19.09.12 -
  2. 08.01.15 08.01.15 - Martin Dugas
  3. 08.06.15 08.06.15 -
Hochgeladen am

8. Juni 2015

DOI

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E3805 Prostate Follow-up PSA Assessment Form NCT00309985

Englisch

INSTRUCTIONS: After patient is off treatment, complete this form for each required follow-up report period (see forms submission schedule).

1 Formulare  
Header
Beschreibung

Header

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
Patient demographics
Beschreibung

Patient demographics

Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
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
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
Data amendment
Beschreibung

Data amendment

Please mark an 'X' if data have been amended.
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
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
On Treatment
Beschreibung

On Treatment

On Treatment Report Period (Arm A since start of treatment)
Beschreibung

Cycle number

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2045829
NCI Thesaurus Property
C25214
NCI Thesaurus Property-2
C25616
NCI Thesaurus ObjectClass
C15368
OFF (CHEMOTHERAPY) TREATMENT
Beschreibung

OFF (CHEMOTHERAPY) TREATMENT

Off Treatment Report Period (since initial registration)
Beschreibung

PersonOff-TreatmentTimePeriodType

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25601
UMLS 2011AA Property-2
C1518544
NCI Thesaurus Property-3
C25207
UMLS 2011AA Property-3
C0040223
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Prostate Specific Antigen (psa)
Beschreibung

Prostate Specific Antigen (psa)

PSA Value (total)
Beschreibung

LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultValue

Datentyp

float

Maßeinheiten
  • ng/ml
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17525
UMLS 2011AA Property
C0138741
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C17220
UMLS 2011AA Property-3
C0041365
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
ng/ml
Date of PSA Assessment
Beschreibung

LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultDate

Datentyp

date

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17525
UMLS 2011AA Property
C0138741
NCI Thesaurus Property-2
C20200
UMLS 2011AA Property-2
C1274040
NCI Thesaurus Property-3
C17220
UMLS 2011AA Property-3
C0041365
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
PSA Value, Upper Limit of Normal
Beschreibung

PSAValue,UpperLimit

Datentyp

float

Comments
Beschreibung

Comments

Comments
Beschreibung

Research Comments

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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
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Ähnliche Modelle

INSTRUCTIONS: After patient is off treatment, complete this form for each required follow-up report period (see forms submission schedule).

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header
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 Group
Patient demographics
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
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)
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)
Item Group
Data amendment
Data amended
Item
Please mark an 'X' if data have been amended.
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended
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)
Item Group
On Treatment
Item
On Treatment Report Period (Arm A since start of treatment)
text
C25284 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25616 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)
CL.1
Code List
On Treatment Report Period (Arm A since start of treatment)
CL Item
Week 12 (Week 12)
Item Group
OFF (CHEMOTHERAPY) TREATMENT
Item
Off Treatment Report Period (since initial registration)
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25601 (NCI Thesaurus Property-2)
C1518544 (UMLS 2011AA Property-2)
C25207 (NCI Thesaurus Property-3)
C0040223 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.2
Code List
Off Treatment Report Period (since initial registration)
CL Item
3 Months (3 Months Post Registration)
CL Item
6 Months (6 Months Post Registration)
CL Item
9 Months (9 Months Post Registration)
CL Item
12 Months (12 Months Post Registration)
CL Item
15 Months (15 Months Post Registration)
CL Item
18 Months (18 Months Post Registration)
CL Item
21 Months Post Registration (21 Months Post Registration)
CL Item
2 Years (24 Months Post Registration)
CL Item
30 Months (30 Months Post Registration)
CL Item
3 Years (36 Months Post Registration)
CL Item
42 Months (42 Months Post Registration)
CL Item
4 Years (48 Months Post Registration)
CL Item
54 Months (54 Months Post Registration)
CL Item
5 Years (60 Months Post Registration)
CL Item
6 Years (72 Months Post-Registration)
CL Item
84 Months Post Registration (84 Months Post-Registration)
CL Item
8 Years (96 Months Post-Registration)
CL Item
9 Years (108 Months Post-Registration)
CL Item
10 Years (120 Months Post-Registration)
Item Group
Prostate Specific Antigen (psa)
LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultValue
Item
PSA Value (total)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C17220 (NCI Thesaurus Property-3)
C0041365 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultDate
Item
Date of PSA Assessment
date
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17525 (NCI Thesaurus Property)
C0138741 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C17220 (NCI Thesaurus Property-3)
C0041365 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
PSAValue,UpperLimit
Item
PSA Value, Upper Limit of Normal
float
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
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)
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