ID

11798

Description

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

Link

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

Keywords

Versions (3)
  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 8/4/15 8/4/15 - Martin Dugas
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August 4, 2015

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

English

045A

1 forms  
  1. StudyEvent: AMC-045 Enrollement Form (ENR)
    1. 045A
General information
Description

General information

Alias
UMLS CUI-1
C1508263
Principal Investigator
Description

PrincipalInvestigatorName

Data type

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
Description

Treatment Begin Date

Data type

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
Description

Karnofsky Performance Status

Data type

integer

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

Age

Data type

integer

Measurement units
  • 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
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Inclusion Criteria
Description

AIDSMalignancyConsortiumPatientInclusionClinicalTrialEligibilityCriteria045Type

Data type

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
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Exclusion Criteria
Description

AIDSMalignancyConsortiumPatientExclusionClinicalTrialEligibilityCriteria045Type

Data type

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
Description

Consent Module

Date Informed Consent Signed
Description

InformedConsentFormSignedDate

Data type

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)
Description

TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3

Data type

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)
Description

PersonSwabCollectionConsentIndicator

Data type

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)
Description

PersonBiopsyConsentIndicator

Data type

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
Description

PersonSpecimenMalignantNeoplasmResearchConsentInd-2

Data type

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)
Description

PatientOtherDiseaseorDisorderClinicalStudyConsentInd-2

Data type

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)
Description

Permission to contact Patient

Data type

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
Description

Comments Module

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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Similar models

045A

1 forms
  1. StudyEvent: AMC-045 Enrollement Form (ENR)
    1. 045A
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
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