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10792

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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

Länk

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

Nyckelord

  1. 2012-09-19 2012-09-19 -
  2. 2015-01-08 2015-01-08 - Martin Dugas
  3. 2015-06-08 2015-06-08 -
Uppladdad den

8 juni 2015

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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    E3805 Prostate Follow-up PSA Assessment Form NCT00309985

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

    Header
    Beskrivning

    Header

    ECOG Protocol Number
    Beskrivning

    Protocol Number ECOG

    Datatyp

    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
    Beskrivning

    Patient ID ECOG

    Datatyp

    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
    Beskrivning

    Generic drug form

    Datatyp

    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
    Beskrivning

    Registration Number

    Datatyp

    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
    Beskrivning

    Patient demographics

    Patient Initials
    Beskrivning

    Patient Initials

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS CUI-1
    C2986440
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus Property
    C25536
    ECOG Protocol Number
    Beskrivning

    Protocol Number ECOG

    Datatyp

    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
    Beskrivning

    Patient ID ECOG

    Datatyp

    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
    Beskrivning

    Study Number Participating Group

    Datatyp

    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
    Beskrivning

    Institution Name

    Datatyp

    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
    Beskrivning

    Trial subject ID Participating Group

    Datatyp

    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
    Beskrivning

    Data amendment

    Please mark an 'X' if data have been amended.
    Beskrivning

    Data amended

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0680532
    NCI Thesaurus ObjectClass
    C25474
    NCI Thesaurus Property
    C25416
    Date data amended
    Beskrivning

    Data amended date

    Datatyp

    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
    Beskrivning

    On Treatment

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

    Cycle number

    Datatyp

    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
    Beskrivning

    OFF (CHEMOTHERAPY) TREATMENT

    Off Treatment Report Period (since initial registration)
    Beskrivning

    PersonOff-TreatmentTimePeriodType

    Datatyp

    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)
    Beskrivning

    Prostate Specific Antigen (psa)

    PSA Value (total)
    Beskrivning

    LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultValue

    Datatyp

    float

    Måttenheter
    • 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
    Beskrivning

    LaboratoryProcedureProstate-SpecificAntigenTumorMarkerResultDate

    Datatyp

    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
    Beskrivning

    PSAValue,UpperLimit

    Datatyp

    float

    Comments
    Beskrivning

    Comments

    Comments
    Beskrivning

    Research Comments

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0947611
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
    Investigator Signature
    Beskrivning

    Investigator Signature

    Datatyp

    text

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

    Investigator Signature Date

    Datatyp

    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

    Similar models

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

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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)
    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)
    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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