ID

11799

Description

Enrollment HIV-Related Kaposi Sarcoma AMC-051 NCT00450320 Sirolimus in Treating Patients With HIV-Related Kaposi's Sarcoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=2FDFA89A-076B-6018-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=2FDFA89A-076B-6018-E044-0003BA3F9857

Keywords

  1. 9/19/12 9/19/12 -
  2. 5/28/15 5/28/15 -
  3. 6/3/15 6/3/15 -
  4. 8/4/15 8/4/15 - Martin Dugas
Uploaded on

August 4, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Enrollment HIV-Related Kaposi Sarcoma AMC-051 NCT00450320

No Instruction available.

  1. StudyEvent: AMC-051 ENR Form (Enrollment)
    1. No Instruction available.
Header Module
Description

Header Module

Principal Investigator
Description

Principal Investigator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C19924
UMLS CUI [1]
C1521895
Projected Start Date of Treatment
Description

Projected Start Date of Treatment

Data type

date

Measurement units
  • DD.MM.YYYY
Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25631
NCI Thesaurus Property
C25431
NCI Thesaurus Property-2
C25275
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI [1]
C3173309
DD.MM.YYYY
Inclusion/exclusion Criteria
Description

Inclusion/exclusion Criteria

Inclusion Criteria
Description

AIDSMalignancyConsortiumPatientInclusionClinicalTrialEligibilityCriteria051Type

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

Exclusion Criteria
Description

AIDSMalignancyConsortiumPatientExclusionClinicalTrialEligibilityCriteria051Type

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
Karnofsky Performance Status
Description

Karnofsky Performance Status

Data type

integer

Measurement units
  • %
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
Informed Consent Date
Description

Informed Consent Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C16468
NCI Thesaurus Property
C25679
UMLS CUI [1]
C2985782
Select the HAART regimen the participant is currently receiving
Description

PatientHighlyActiveAntiretroviralTherapyRegimenType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C16165
UMLS 2011AA Property
C0887947
NCI Thesaurus Property-2
C15697
UMLS 2011AA Property-2
C0040808
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-051 ENR Form (Enrollment)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
Principal Investigator
Item
Principal Investigator
text
C25191 (NCI Thesaurus ValueDomain)
C25364 (NCI Thesaurus Property)
C19924 (NCI Thesaurus ObjectClass)
C1521895 (UMLS CUI [1])
Treatment Begin Date
Item
Projected Start Date of Treatment
date
C15368 (NCI Thesaurus ObjectClass)
C25631 (NCI Thesaurus ObjectClass-2)
C25431 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C3173309 (UMLS CUI [1])
Item Group
Inclusion/exclusion Criteria
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)
Code List
Inclusion Criteria
CL Item
Date Informed Consent Obtained (Date informed consent obtained)
CL Item
Does The Participant Have A Ast (sgot) And Alt (sgpt) <=2.5 Times The Uln (Does the participant have a AST (SGOT) and ALT (SGPT) <=2.5 times the ULN)
CL Item
Does The Participant Have A Fasting Triglyceride Level Of <= 400 Mg/dl (4.5 Mmol/l), And A Total Cholesterol Level Of <= 300 Mg/dl (7.8 Mmol/l) (Does the participant have a fasting triglyceride level of <= 400 mg/dL (4.5 mmol/L), and a total cholesterol level of <= 300 mg/dL (7.8 mmol/L))
CL Item
Does The Participant Have A Total Bilirubin <= 1.5 Times Upper Limit Of Normal (uln) (Does the participant have a Total bilirubin <= 1.5 times upper limit of normal (ULN))
CL Item
Does The Participant Have Biopsy-proven Ks Involving The Skin, Lymph Nodes, Oral Cavity, Gi Tract And/or Lungs (gi And Pulmonary Involvement Must Be Asymptomatic Or Minimally Symptomatic And Not Require Systemic Cytotoxic Therapy) (Does the participant have biopsy-proven KS involving the skin, lymph nodes, oral cavity, GI tract and/or lungs (GI and pulmonary involvement must be asymptomatic or minimally symptomatic and not require systemic cytotoxic therapy))
CL Item
Does The Participant Have Serologic Documentation Of Hiv Infection At Any Time Prior To Study Entry, As Evidenced By Positive Elisa, Positive Western Blot, Or Other Federally Approved Licensed Hiv Test, Or A Detectable Blood Level Of Hiv Rna (Does the participant have serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive ELISA, positive Western Blot, or other federally approved licensed HIV test, or a detectable blood level of HIV RNA)
CL Item
Does The Participant Have The Ability And Willingness To Give Informed Consent (Does the participant have the ability and willingness to give informed consent)
CL Item
Does The Participant Have The Following Laboratory Parameters Within 21 Days Prior To Study Entry: Hemoglobin >= 8.0 Gm/dl; Absolute Neutrophil Count >= 1000 Cells/mm3; Platelet Count >= 75,000/mm3 (Does the participant have the following laboratory parameters within 21 days prior to study entry: Hemoglobin >= 8.0 gm/dL; Absolute neutrophil count >= 1000 cells/mm3; Platelet count >= 75,000/mm3)
CL Item
Does The Participant, Male Or Female, Of Reproductive Age, Agree To Employ An Effective Barrier Method Of Birth Control Throughout The Study And For Up To 3 Months Following Discontinuation Of Study Drug (Does the participant, male or female, of reproductive age, agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug)
CL Item
Gfr > 40 Ml/min (calculated By The Cockcroft-gault Equation), Calculated As Follows For Males = 140 - Age [years]) X (body Weight [kg]) / (72) X (serum Creatinine [mg/dl]; For Females = 0.85 X Male Value (GFR > 40 mL/min (calculated by the Cockcroft-Gault equation), calculated as follows For males = 140 - age [years]) x (body weight [kg]) / (72) x (serum creatinine [mg/dL]; For females = 0.85 x male value)
CL Item
Has The Participant Been On Stable Anti-retroviral Therapy For At Least 12 Weeks With A Pi-based Or Nnrti-based Regimen Of At Least Three Drugs, With No Intention To Change The Regimen Within 8 Weeks Of Starting Study Drug (Has the participant been on stable anti-retroviral therapy for at least 12 weeks with a PI-based or NNRTI-based regimen of at least three drugs, with no intention to change the regimen within 8 weeks of starting study drug)
CL Item
Has The Participant Had No Prior Treatment With Rapamycin (Has the participant had no prior treatment with rapamycin)
CL Item
If The Participant Is Female, Did She Have A Negative Pregnancy Test Within 72 Hours Before Initiation Of Study Drug Dosing (If the participant is female, did she have a negative pregnancy test within 72 hours before initiation of study drug dosing)
CL Item
Is The Participant's Cd4 Count >50 Cells/ul And Serum Hiv Rna Level <400 Copies/ml (Is the participant's CD4 count >50 cells/uL and serum HIV RNA level <400 copies/mL)
CL Item
Is The Participant's Life Expectancy 3 Months Or More (Is the participant's life expectancy 3 months or more)
CL Item
Is The Participant, In The Opinion Of The Investigator, Capable Of Complying With This Protocol (Is the participant, in the opinion of the Investigator, capable of complying with this protocol)
CL Item
Karnofsky Performance Status (must Be > 60%) (Karnofsky Performance Status (must be > 60%))
CL Item
Participant's Age (in Years) (Participant's age (in years))
CL Item
Regarding The Participant's Spot Urine Protein: Is The Creatinine Ratio <= 0.5 And/or Proteinuria <= 500 Mg/day (Regarding the participant's spot urine protein: Is the creatinine ratio <= 0.5 and/or proteinuria <= 500 mg/day)
Item Group
Exclusion Criteria
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)
Code List
Exclusion Criteria
CL Item
Does The Participant Have A Grade Iii/iv Cardiac Disease As Defined By The New York Heart Association Criteria (e.g., Congestive Heart Failure, Myocardial Infarction Within 6 Months Of Study) (Does the participant have a Grade III/IV cardiac disease as defined by the New York Heart Association criteria (e.g., congestive heart failure, myocardial infarction within 6 months of study))
CL Item
Does The Participant Have A History Of Prior Or Concurrent Malignancy Except For Treated Basal Cell Skin Cancer Or A Cervical Carcinoma In Situ (Does the participant have a history of prior or concurrent malignancy except for treated basal cell skin cancer or a cervical carcinoma in situ)
CL Item
Does The Participant Have An Acute Or Known Chronic Liver Disease (e.g., Chronic Active Hepatitis, Cirrhosis) (participants With Known Hepatitis C Infection But With Documentation Of No Or Minimal Fibrosis On Liver Biopsy May Be Enrolled) (Does the participant have an acute or known chronic liver disease (e.g., chronic active hepatitis, cirrhosis) (Participants with known Hepatitis C infection but with documentation of no or minimal fibrosis on liver biopsy may be enrolled))
CL Item
Does The Participant Have Another Severe And/or Life-threatening Medical Disease (Does the participant have another severe and/or life-threatening medical disease)
CL Item
Does The Participant Have Any Known Hypersensitivity To Rapamycin Or Its Derivatives Or Macrolide Antibiotics (Does the participant have any known hypersensitivity to rapamycin or its derivatives or macrolide antibiotics)
CL Item
Does The Participant Have Concurrent Active Opportunistic Infection (oi) (Does the participant have concurrent active opportunistic infection (OI))
CL Item
Has The Participant Had Acute Treatment For An Infection Or Other Serious Medical Illness Within 14 Days Prior To Study Entry; Evidence Of Infiltrate, Cavitation Or Consolidation On Chest X-ray Obtained Before Or At The Time Of The Screening Evaluation (Has the participant had acute treatment for an infection or other serious medical illness within 14 days prior to study entry; evidence of infiltrate, cavitation or consolidation on chest x-ray obtained before or at the time of the screening evaluation)
CL Item
Has The Participant Had Antineoplastic Treatment For Ks (including Chemotherapy, Radiation Therapy, Biological Therapy, Or Investigational Therapy) Within 4 Weeks (6 Weeks For Nitrosourea Or Mitomycin-c) Of Study Entry (Has the participant had antineoplastic treatment for KS (including chemotherapy, radiation therapy, biological therapy, or investigational therapy) within 4 weeks (6 weeks for nitrosourea or mitomycin-C) of study entry)
CL Item
Has The Participant Had Major Surgery Within 2 Weeks Prior To Study Entry (Has the participant had major surgery within 2 weeks prior to study entry)
CL Item
Has The Participant Had Previous Local Therapy Of Any Ks Indicator Lesion Within 60 Days, Unless The Lesion Has Progressed Since Treatment (Has the participant had previous local therapy of any KS indicator lesion within 60 days, unless the lesion has progressed since treatment)
CL Item
Has The Participant Had Systemic Corticosteroid Treatment, Other Than Replacement Doses (Has the participant had systemic corticosteroid treatment, other than replacement doses)
CL Item
Has The Participant Used Any Investigational Drug Or Treatment Up To 4 Weeks Before Randomization (Has the participant used any investigational drug or treatment up to 4 weeks before randomization)
CL Item
If The Participant Is Female, Is She Pregnant Or Breast-feeding (If the participant is female, is she pregnant or breast-feeding)
CL Item
Is The Participant Receiving Treatment With Agents Or Medications, Other Than Antiretroviral Drugs Used To Treat Hiv Infection, Which Would Interfere With The Metabolism Or Excretion Of Rapamycin (Is the participant receiving treatment with agents or medications, other than antiretroviral drugs used to treat HIV infection, which would interfere with the metabolism or excretion of rapamycin)
Item
Karnofsky Performance Status
integer
C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0206065 (UMLS CUI [1])
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])
Informed Consent Date
Item
Informed Consent Date
date
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C25679 (NCI Thesaurus Property)
C2985782 (UMLS CUI [1])
Item
Select the HAART regimen the participant is currently receiving
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16165 (NCI Thesaurus Property)
C0887947 (UMLS 2011AA Property)
C15697 (NCI Thesaurus Property-2)
C0040808 (UMLS 2011AA Property-2)
Code List
Select the HAART regimen the participant is currently receiving
CL Item
Nnrti-based Haart Regimen (NNRTI-based HAART Regimen)
CL Item
Pi-based Haart Regimen (PI-based HAART Regimen)
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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