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11798

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Cisplatin, Fluorouracil, Cetuximab, and Radiation Therapy in Treating Patients With HIV and Stage I, Stage II, or Stage III Anal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1CB5F031-5BC1-01E3-E044-0003BA3F9857

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1CB5F031-5BC1-01E3-E044-0003BA3F9857

Nyckelord

Versioner (3)
  1. 2014-12-18 2014-12-18 - Martin Dugas
  2. 2015-01-09 2015-01-09 - Martin Dugas
  3. 2015-08-04 2015-08-04 - Martin Dugas
Uppladdad den

4 augusti 2015

DOI

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Creative Commons BY-NC 3.0 Legacy
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    Enrollment Form HIV Anal Cancer AMC-045 NCT00324415

    Engelsk

    045A

    1 Formulär  
    1. StudyEvent: AMC-045 Enrollement Form (ENR)
      1. 045A
    General information
    Beskrivning

    General information

    Alias
    UMLS CUI-1
    C1508263
    Principal Investigator
    Beskrivning

    PrincipalInvestigatorName

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25191
    UMLS 2011AA ValueDomain
    C1547383
    NCI Thesaurus Property
    C25364
    UMLS 2011AA Property
    C0600091
    NCI Thesaurus ObjectClass
    C19924
    UMLS 2011AA ObjectClass
    C1521895
    Projected Start Date of Treatment
    Beskrivning

    Treatment Begin Date

    Datatyp

    date

    Alias
    NCI Thesaurus ObjectClass
    C15368
    NCI Thesaurus ObjectClass-2
    C25631
    NCI Thesaurus Property
    C25431
    UMLS CUI-1
    C3173309
    NCI Thesaurus Property-2
    C25275
    NCI Thesaurus ValueDomain
    C25164
    NCI Thesaurus ValueDomain-2
    C25431
    Karnofsky Performance Status
    Beskrivning

    Karnofsky Performance Status

    Datatyp

    integer

    Alias
    NCI Thesaurus Property
    C25367
    NCI Thesaurus ObjectClass
    C20641
    NCI Thesaurus ValueDomain
    C25338
    UMLS CUI [1]
    C0206065
    Age
    Beskrivning

    Age

    Datatyp

    integer

    Måttenheter
    • years
    Alias
    NCI Thesaurus ObjectClass
    C16960
    NCI Thesaurus ValueDomain
    C29848
    NCI Thesaurus ValueDomain-2
    C25463
    NCI Thesaurus Property
    C25150
    UMLS CUI [1]
    C0001779
    years
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    Inclusion Criteria
    Beskrivning

    AIDSMalignancyConsortiumPatientInclusionClinicalTrialEligibilityCriteria045Type

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass-2
    C19707
    UMLS 2011AA ObjectClass-2
    C1515830
    NCI Thesaurus Property
    C16112
    UMLS 2011AA Property
    C1516637
    NCI Thesaurus Property-2
    C25532
    UMLS 2011AA Property-2
    C1512693
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251
    Exclusion Criteria
    Beskrivning

    AIDSMalignancyConsortiumPatientExclusionClinicalTrialEligibilityCriteria045Type

    Datatyp

    text

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus ObjectClass-2
    C19707
    UMLS 2011AA ObjectClass-2
    C1515830
    NCI Thesaurus Property
    C16112
    UMLS 2011AA Property
    C1516637
    NCI Thesaurus Property-2
    C25370
    UMLS 2011AA Property-2
    C0680251
    NCI Thesaurus ValueDomain
    C25284
    UMLS 2011AA ValueDomain
    C0332307
    Consent Module
    Beskrivning

    Consent Module

    Date Informed Consent Signed
    Beskrivning

    InformedConsentFormSignedDate

    Datatyp

    date

    Alias
    NCI Thesaurus ValueDomain
    C25164
    UMLS 2011AA ValueDomain
    C0011008
    NCI Thesaurus ValueDomain-2
    C25367
    NCI Thesaurus ObjectClass
    C16468
    UMLS 2011AA ObjectClass
    C0009797
    NCI Thesaurus Property
    C25679
    Patient's initial consent given for diagnostic biopsy specimen use for research on future studies (This procedure has already been performed and requires no additional procedures)
    Beskrivning

    TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3

    Datatyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C12801
    UMLS 2011AA ObjectClass
    C0040300
    NCI Thesaurus ObjectClass-2
    C19157
    UMLS 2011AA ObjectClass-2
    C0370003
    NCI Thesaurus Property
    C15319
    NCI Thesaurus Property-2
    C25648
    UMLS 2011AA Property
    C0439849
    NCI Thesaurus Property-3
    C9305
    UMLS 2011AA Property-2
    C0006826
    NCI Thesaurus Property-4
    C25460
    UMLS 2011AA Property-3
    C1511481
    NCI Thesaurus ValueDomain
    C38148
    UMLS 2011AA ValueDomain
    C1512699
    Patient's initial consent given for anal swab specimen use for research on future studies (This procedure requires putting an anal swab in the anal canal)
    Beskrivning

    PersonSwabCollectionConsentIndicator

    Datatyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C25453
    UMLS 2011AA Property
    C1516698
    NCI Thesaurus Property-2
    C25460
    UMLS 2011AA Property-2
    C1511481
    NCI Thesaurus Property-3
    C17627
    UMLS 2011AA Property-3
    C1261188
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    Patient's initial consent given for an additional diagnostic biopsy for research on future studies (This will require another biopsy to be done)
    Beskrivning

    PersonBiopsyConsentIndicator

    Datatyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    NCI Thesaurus Property
    C15189
    UMLS 2011AA Property
    C0005558
    NCI Thesaurus Property-2
    C25460
    UMLS 2011AA Property-2
    C1511481
    Patient's Initial Consent given for specimen kept for future use in research to learn about, prevent, or treat cancer
    Beskrivning

    PersonSpecimenMalignantNeoplasmResearchConsentInd-2

    Datatyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25190
    UMLS 2011AA ObjectClass
    C0027361
    NCI Thesaurus Property
    C15319
    NCI Thesaurus Property-2
    C9305
    UMLS 2011AA Property
    C0006826
    NCI Thesaurus Property-3
    C19157
    UMLS 2011AA Property-2
    C0370003
    NCI Thesaurus Property-4
    C25460
    UMLS 2011AA Property-3
    C1511481
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Patient's initial consent given for specimen(s) may be kept for use in research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
    Beskrivning

    PatientOtherDiseaseorDisorderClinicalStudyConsentInd-2

    Datatyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS 2011AA ObjectClass
    C0030705
    NCI Thesaurus Property
    C17649
    UMLS 2011AA Property
    C0205394
    NCI Thesaurus Property-2
    C2991
    UMLS 2011AA Property-2
    C0012634
    NCI Thesaurus Property-3
    C15206
    UMLS 2011AA Property-3
    C0008972
    NCI Thesaurus Property-4
    C25460
    UMLS 2011AA Property-4
    C1511481
    NCI Thesaurus ValueDomain
    C38147
    UMLS 2011AA ValueDomain
    C1512698
    Patient's initial consent given for further contact to participate in research on future studies (their doctor or someone from the AMC)
    Beskrivning

    Permission to contact Patient

    Datatyp

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C16960
    UMLS CUI-1
    C1522577
    NCI Thesaurus Property
    C67527
    UMLS CUI-2
    C0521104
    NCI Thesaurus Property-2
    C25460
    NCI Thesaurus Property-3
    C16452
    NCI Thesaurus ValueDomain
    C38148
    Comments Module
    Beskrivning

    Comments Module

    Comments
    Beskrivning

    Research Comments

    Datatyp

    text

    Alias
    NCI Thesaurus ValueDomain
    C25704
    UMLS CUI-1
    C0947611
    NCI Thesaurus ObjectClass
    C15319
    NCI Thesaurus Property
    C25393
    Tillbaka till toppen

    Similar models

    045A

    1 Formulär
    1. StudyEvent: AMC-045 Enrollement Form (ENR)
      1. 045A
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    General information
    C1508263 (UMLS CUI-1)
    PrincipalInvestigatorName
    Item
    Principal Investigator
    text
    C25191 (NCI Thesaurus ValueDomain)
    C1547383 (UMLS 2011AA ValueDomain)
    C25364 (NCI Thesaurus Property)
    C0600091 (UMLS 2011AA Property)
    C19924 (NCI Thesaurus ObjectClass)
    C1521895 (UMLS 2011AA ObjectClass)
    Treatment Begin Date
    Item
    Projected Start Date of Treatment
    date
    C15368 (NCI Thesaurus ObjectClass)
    C25631 (NCI Thesaurus ObjectClass-2)
    C25431 (NCI Thesaurus Property)
    C3173309 (UMLS CUI-1)
    C25275 (NCI Thesaurus Property-2)
    C25164 (NCI Thesaurus ValueDomain)
    C25431 (NCI Thesaurus ValueDomain-2)
    Item
    Karnofsky Performance Status
    integer
    C25367 (NCI Thesaurus Property)
    C20641 (NCI Thesaurus ObjectClass)
    C25338 (NCI Thesaurus ValueDomain)
    C0206065 (UMLS CUI [1])
    KarnofskyPerformanceStatusScore
    Code List
    Karnofsky Performance Status
    CL Item
    Dead (0)
    CL Item
    Moribund, Fatal Processes Progressing Rapidly (10)
    CL Item
    Normal, No Complaints, No Evidence Of Disease (100)
    CL Item
    Very Sick, Hospitalization Indicated. Death Not Imminent (20)
    CL Item
    Severely Disabled, Hospitalization Indicated. Death Not Imminent (30)
    CL Item
    Disabled, Requires Special Care And Assistance (40)
    CL Item
    Requires Considerable Assistance And Frequent Medical Care (50)
    CL Item
    Requires Occasional Assistance, But Is Able To Care For Most Of His/her Needs (60)
    CL Item
    Cares For Self, Unable To Carry On Normal Activity Or To Do Active Work (70)
    CL Item
    Normal Activity With Effort; Some Signs Or Symptoms Of Disease (80)
    CL Item
    Able To Carry On Normal Activity; Minor Signs Or Symptoms Of Disease (90)
    Age
    Item
    Age
    integer
    C16960 (NCI Thesaurus ObjectClass)
    C29848 (NCI Thesaurus ValueDomain)
    C25463 (NCI Thesaurus ValueDomain-2)
    C25150 (NCI Thesaurus Property)
    C0001779 (UMLS CUI [1])
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    Item
    Inclusion Criteria
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C19707 (NCI Thesaurus ObjectClass-2)
    C1515830 (UMLS 2011AA ObjectClass-2)
    C16112 (NCI Thesaurus Property)
    C1516637 (UMLS 2011AA Property)
    C25532 (NCI Thesaurus Property-2)
    C1512693 (UMLS 2011AA Property-2)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL.1
    Code List
    Inclusion Criteria
    CL Item
    Date Informed Consent Obtained (Date informed consent obtained)
    CL Item
    Does The Patient Have Adequate Hematologic Function Within 14 Days Of Study Enrollment: Hemoglobin >= 10 G/dl, Platelet Count >= 100,000/mm^3, And Anc >= 1500/mm^3? (Does the patient have adequate hematologic function within 14 days of study enrollment: Hemoglobin >= 10 g/dl, Platelet count >= 100,000/mm^3, and ANC >= 1500/mm^3?)
    CL Item
    Does The Patient Have Adequate Hepatic Function Within 14 Days Of Study Enrollment: Ast And Alt <= 3 X Uln, And T. Bili <= 2 X Uln? (if Related To Antiretroviral Use, Then The Direct Bilirubin Must Be <= 2 X Uln.) (Does the patient have adequate hepatic function within 14 days of study enrollment: AST and ALT <= 3 X ULN, and T. Bili <= 2 X ULN? (If related to antiretroviral use, then the Direct Bilirubin must be <= 2 X ULN.))
    CL Item
    Does The Patient Have Creatinine <= 1.5 X The Upper Limits Of Normal (uln) Or A Creatinine Clearance Above 60 Ml/min Within 14 Days Of Study Enrollment? (Does the patient have creatinine <= 1.5 X the upper limits of normal (ULN) or a creatinine clearance above 60 mL/min within 14 days of study enrollment?)
    CL Item
    Does The Patient Have Documented Hiv Infection? (documentation May Be By Antibody Detection, Culture, Or Quantitative Assay Of Plasma Hiv Rna.) (Does the patient have documented HIV infection? (Documentation may be by antibody detection, culture, or quantitative assay of plasma HIV RNA.))
    CL Item
    Does The Patient Have Histologically Proven Stage I-iiib Invasive Anal Canal Or Perianal (anal Margin) Squamous Cell Carcinoma? (this May Include Tumors Of Non-keratinizing Histology Such As Basoloid, Transitional Cell, Or Cloacogenic Histology.) (Does the patient have histologically proven stage I-IIIB invasive anal canal or perianal (anal margin) squamous cell carcinoma? (This may include tumors of non-keratinizing histology such as basoloid, transitional cell, or cloacogenic histology.))
    CL Item
    Does The Patient Have The Ability And Willingness To Give Informed Consent? (Does the patient have the ability and willingness to give informed consent?)
    CL Item
    Has The Patient Had No Prior Chemotherapy Or No Prior Irradiation For This Malignancy? (patients With A History Of Prior Irradiation To The Planned Irradiation Field For Another Condition (eg, Kaposi's Sarcoma) May Be Eligible After Consultation.) (Has the patient had no prior chemotherapy or no prior irradiation for this malignancy? (Patients with a history of prior irradiation to the planned irradiation field for another condition (eg, Kaposi's sarcoma) may be eligible after consultation.))
    CL Item
    Karnofsky Performance Status (must Be > 60%) (Karnofsky Performance Status (must be > 60%))
    CL Item
    Patient's Age (in Years) (Patient's age (in years))
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    Item
    Exclusion Criteria
    text
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C19707 (NCI Thesaurus ObjectClass-2)
    C1515830 (UMLS 2011AA ObjectClass-2)
    C16112 (NCI Thesaurus Property)
    C1516637 (UMLS 2011AA Property)
    C25370 (NCI Thesaurus Property-2)
    C0680251 (UMLS 2011AA Property-2)
    C25284 (NCI Thesaurus ValueDomain)
    C0332307 (UMLS 2011AA ValueDomain)
    CL.2
    Code List
    Exclusion Criteria
    CL Item
    Does The Patient Have A Medical Or Psychiatric Illness That Precludes Ability To Give Informed Consent Or Is Likely To Interfere With The Ability To Comply With The Protocol Stipulations? (Does the patient have a medical or psychiatric illness that precludes ability to give informed consent or is likely to interfere with the ability to comply with the protocol stipulations?)
    CL Item
    Does The Patient Have Acute, Active, Serious, Uncontrolled Opportunistic Infection? (patients With A Cd4 Count < 50/ul Will Be Excluded If They Have Had An Opportunistic Infection Within The Past 6 Months, Or If There Is Evidence Of Resistance.) (Does the patient have acute, active, serious, uncontrolled opportunistic infection? (Patients with a CD4 count < 50/uL will be excluded if they have had an opportunistic infection within the past 6 months, or if there is evidence of resistance.))
    CL Item
    Does The Patient Have Grade 2, 3, 4 Neuropathy? (Does the patient have Grade 2, 3, 4 neuropathy?)
    CL Item
    Does The Patient Have Severe (grade 3 Or 4) Or Poorly Controlled Diarrhea? (Does the patient have severe (grade 3 or 4) or poorly controlled diarrhea?)
    CL Item
    Has The Patient Been Diagnosed With An Invasive Malignancy Within The Past 24 Months? (excluding In Situ Cervical Cancer, Anal Dysplasia Or Carcinoma In Situ, Non-melanoma Skin Carcinoma, Kaposi's Sarcoma That Has Not Required Systemic Chemotherapy.) (Has the patient been diagnosed with an invasive malignancy within the past 24 months? (excluding in situ cervical cancer, anal dysplasia or carcinoma in situ, non-melanoma skin carcinoma, Kaposi's sarcoma that has not required systemic chemotherapy.))
    CL Item
    If The Patient Is A Female, Is She Pregnant Or Nursing? (If the patient is a female, is she pregnant or nursing?)
    InformedConsentFormSignedDate
    Item
    Date Informed Consent Signed
    date
    C25164 (NCI Thesaurus ValueDomain)
    C0011008 (UMLS 2011AA ValueDomain)
    C25367 (NCI Thesaurus ValueDomain-2)
    C16468 (NCI Thesaurus ObjectClass)
    C0009797 (UMLS 2011AA ObjectClass)
    C25679 (NCI Thesaurus Property)
    TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3
    Item
    Patient's initial consent given for diagnostic biopsy specimen use for research on future studies (This procedure has already been performed and requires no additional procedures)
    boolean
    C12801 (NCI Thesaurus ObjectClass)
    C0040300 (UMLS 2011AA ObjectClass)
    C19157 (NCI Thesaurus ObjectClass-2)
    C0370003 (UMLS 2011AA ObjectClass-2)
    C15319 (NCI Thesaurus Property)
    C25648 (NCI Thesaurus Property-2)
    C0439849 (UMLS 2011AA Property)
    C9305 (NCI Thesaurus Property-3)
    C0006826 (UMLS 2011AA Property-2)
    C25460 (NCI Thesaurus Property-4)
    C1511481 (UMLS 2011AA Property-3)
    C38148 (NCI Thesaurus ValueDomain)
    C1512699 (UMLS 2011AA ValueDomain)
    PersonSwabCollectionConsentIndicator
    Item
    Patient's initial consent given for anal swab specimen use for research on future studies (This procedure requires putting an anal swab in the anal canal)
    boolean
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25453 (NCI Thesaurus Property)
    C1516698 (UMLS 2011AA Property)
    C25460 (NCI Thesaurus Property-2)
    C1511481 (UMLS 2011AA Property-2)
    C17627 (NCI Thesaurus Property-3)
    C1261188 (UMLS 2011AA Property-3)
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    PersonBiopsyConsentIndicator
    Item
    Patient's initial consent given for an additional diagnostic biopsy for research on future studies (This will require another biopsy to be done)
    boolean
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    C15189 (NCI Thesaurus Property)
    C0005558 (UMLS 2011AA Property)
    C25460 (NCI Thesaurus Property-2)
    C1511481 (UMLS 2011AA Property-2)
    PersonSpecimenMalignantNeoplasmResearchConsentInd-2
    Item
    Patient's Initial Consent given for specimen kept for future use in research to learn about, prevent, or treat cancer
    boolean
    C25190 (NCI Thesaurus ObjectClass)
    C0027361 (UMLS 2011AA ObjectClass)
    C15319 (NCI Thesaurus Property)
    C9305 (NCI Thesaurus Property-2)
    C0006826 (UMLS 2011AA Property)
    C19157 (NCI Thesaurus Property-3)
    C0370003 (UMLS 2011AA Property-2)
    C25460 (NCI Thesaurus Property-4)
    C1511481 (UMLS 2011AA Property-3)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    PatientOtherDiseaseorDisorderClinicalStudyConsentInd-2
    Item
    Patient's initial consent given for specimen(s) may be kept for use in research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C0030705 (UMLS 2011AA ObjectClass)
    C17649 (NCI Thesaurus Property)
    C0205394 (UMLS 2011AA Property)
    C2991 (NCI Thesaurus Property-2)
    C0012634 (UMLS 2011AA Property-2)
    C15206 (NCI Thesaurus Property-3)
    C0008972 (UMLS 2011AA Property-3)
    C25460 (NCI Thesaurus Property-4)
    C1511481 (UMLS 2011AA Property-4)
    C38147 (NCI Thesaurus ValueDomain)
    C1512698 (UMLS 2011AA ValueDomain)
    Permission to contact Patient
    Item
    Patient's initial consent given for further contact to participate in research on future studies (their doctor or someone from the AMC)
    boolean
    C16960 (NCI Thesaurus ObjectClass)
    C1522577 (UMLS CUI-1)
    C67527 (NCI Thesaurus Property)
    C0521104 (UMLS CUI-2)
    C25460 (NCI Thesaurus Property-2)
    C16452 (NCI Thesaurus Property-3)
    C38148 (NCI Thesaurus ValueDomain)
    Item Group
    Comments Module
    Research Comments
    Item
    Comments
    text
    C25704 (NCI Thesaurus ValueDomain)
    C0947611 (UMLS CUI-1)
    C15319 (NCI Thesaurus ObjectClass)
    C25393 (NCI Thesaurus Property)
    Tillbaka till toppen 

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