ID

524

Description

AMC-046 Enrollment Form (ENR) Segment B Cidofovir in Treating HIV-Infected Patients With High-Grade Squamous Intraepithelial Lesions of the Skin Near the Anus Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3BC16E2A-1483-2256-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3BC16E2A-1483-2256-E044-0003BA3F9857

Keywords

  1. 8/26/12 8/26/12 -
  2. 3/19/15 3/19/15 - Martin Dugas
Uploaded on

August 26, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Anal Cancer NCT00550589 Registration - AMC-046 Enrollment Form (ENR) Segment B - 2685843v1.0

No Instruction available.

  1. StudyEvent: AMC-046 Enrollment Form (ENR) Segment B
    1. No Instruction available.
Header Module
Description

Header Module

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 (mm/dd/yyyy)
Description

TreatmentProjectedBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25631
NCI Thesaurus Property
C25431
UMLS 2011AA Property
C0439659
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
Inclusion Criteria
Description

Inclusion Criteria

Inclusion Criteria
Description

AIDSMalignancyConsortiumPatientInclusionClinicalTrialEligibilityCriteria046Type

Data type

text

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

Exclusion Criteria

Karnofsky Performance Status
Description

KarnofskyPerformanceStatusScore

Data type

text

Alias
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820
Date of Biopsy
Description

BiopsyDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Exclusion Criteria
Description

Exclusion Criteria

Exclusion Criteria
Description

AIDSMalignancyConsortiumPatientExclusionClinicalTrialEligibilityCriteria046Type

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass
C19707
UMLS 2011AA ObjectClass
C1515830
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Comments
Description

Comments

Comments
Description

ResearchCommentsText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411

Similar models

No Instruction available.

  1. StudyEvent: AMC-046 Enrollment Form (ENR) Segment B
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
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)
TreatmentProjectedBeginDate
Item
Projected Start Date of Treatment (mm/dd/yyyy)
date
C15368 (NCI Thesaurus ObjectClass)
C25631 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
Item Group
Inclusion Criteria
Item
Inclusion Criteria
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19707 (NCI Thesaurus ObjectClass)
C1515830 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25532 (NCI Thesaurus Property)
C1512693 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Inclusion Criteria
CL Item
Will The Participant Practice Adequate Birth Control To Prevent Pregnancy While Receiving Treatment And For Three Months After Treatment Is Discontinued (Will the participant practice adequate birth control to prevent pregnancy while receiving treatment and for three months after treatment is discontinued)
CL Item
Were The Following Laboratory Parameters Met And Performed Within 28 Days Prior To Study Entry: Hemoglobin (>= 8 G/dl); Anc (>= 1,000 Cells/mm^3); Platelet Count (>= 75,000/mm^3); Creatinine (< 1.5 X Uln); Ast (sgot) And Alt (sgpt) <= 3 X Uln (Were the following laboratory parameters met and performed within 28 days prior to study entry: Hemoglobin (>= 8 g/dl); ANC (>= 1,000 cells/mm^3); Platelet count (>= 75,000/mm^3); Creatinine (< 1.5 x ULN); AST (SGOT) and ALT (SGPT) <= 3 x ULN)
CL Item
Does (do) The Perianal Lesion(s) Have A Surface Area Of At Least 3 Square Centimeters (Does (Do) the perianal lesion(s) have a surface area of at least 3 square centimeters)
CL Item
Does The Participant Have A Biopsy-proven Perianal Hsil Within 12 Weeks Of Study Entry (Does the participant have a biopsy-proven perianal HSIL within 12 weeks of study entry)
CL Item
Date Of Biopsy (Date of biopsy)
CL Item
Does The Participant Have A Cd4 Count Of >200 (Does the participant have a CD4 count of >200)
CL Item
Does The Participant Want To Initiate Haart In The Next 12 Weeks (Does the participant want to initiate HAART in the next 12 weeks)
CL Item
Has The Participant Been On Stable Haart Therapy For At Least 12 Weeks Prior To Enrollment (Has the participant been on stable HAART therapy for at least 12 weeks prior to enrollment)
CL Item
Has The Participant Completely Healed From Treatment (Has the participant completely healed from treatment)
CL Item
Has The Participant Undergone Ablative/surgical Treatment Of Perianal Dysplasia (Has the participant undergone ablative/surgical treatment of perianal dysplasia)
CL Item
Has The Skin At The Site Of The Pretreatment Biopsy Re-epithelialized (Has the skin at the site of the pretreatment biopsy re-epithelialized)
CL Item
Is The Elevated Bilirubin Felt To Be Secondary To Indinavir Therapy (Is the elevated bilirubin felt to be secondary to Indinavir therapy)
CL Item
Is The Participant Currently Receiving Haart Therapy (Is the participant currently receiving HAART therapy)
CL Item
Is The Participant Receiving No Antiretroviral Therapy Or A Non-haart Antiretroviral Regimen (Is the participant receiving no antiretroviral therapy or a non-HAART antiretroviral regimen)
CL Item
Is The Total Bilirubin <= 1.5 X Uln (Is the total bilirubin <= 1.5 x ULN)
CL Item
Is Total Bilirubin <= 3.5 Mg/dl And Is Direct Bilirubin Normal (Is total bilirubin <= 3.5 mg/dl and is direct bilirubin normal)
CL Item
Karnofsky Performance Status (Karnofsky performance status)
Item Group
Exclusion Criteria
KarnofskyPerformanceStatusScore
Item
Karnofsky Performance Status
text
C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)
BiopsyDate
Item
Date of Biopsy
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
Item Group
Exclusion Criteria
Item
Exclusion Criteria
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19707 (NCI Thesaurus ObjectClass)
C1515830 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Exclusion Criteria
CL Item
Has The Subject Received Topical Treatment For Perianal Dysplasia Within 4 Weeks Of Study Entry (Has the subject received topical treatment for perianal dysplasia within 4 weeks of study entry)
CL Item
Does The Participant Have Acute, Active Opportunistic Infection (other Than Oral Thrush, Yeast Vaginitis, Or Genital Herpes) Within The Last 14 Days (Does the participant have acute, active opportunistic infection (other than oral thrush, yeast vaginitis, or genital herpes) within the last 14 days)
CL Item
Is The Participant Receiving Acute Treatment For An Infection (other Than Oral Thrush, Yeast Vaginitis Or Genital Herpes) Or Other Serious Medical Illness Within 14 Days Of Study Entry (Is the participant receiving acute treatment for an infection (other than oral thrush, yeast vaginitis or genital herpes) or other serious medical illness within 14 days of study entry)
Item Group
Comments
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)

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