ID

11627

Description

AMC-061 Enrollment Form (ENR) NCT00890747 Sunitinib Malate in Treating HIV-Positive Patients With Cancer Undergoing Highly Active Antiretroviral Therapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6DBDC738-44D1-D324-E040-BB89AD433B23

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=6DBDC738-44D1-D324-E040-BB89AD433B23

Keywords

Versions (3)
  1. 8/26/12 8/26/12 -
  2. 7/8/15 7/8/15 -
  3. 7/8/15 7/8/15 -
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July 8, 2015

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Creative Commons BY-NC 3.0 Legacy
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AMC-061 Enrollment Form (ENR) NCT00890747

English

No Instruction available.

1 forms  
  1. StudyEvent: AMC-061 Enrollment Form (ENR)
    1. No Instruction available.
Header Module
Description

Header Module

Projected Start Date of Treatment (mm/dd/yyyy)
Description

Projected Start Date of Treatment (mm/dd/yyyy)

Data type

date

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
UMLS CUI-2
C0016538
Inclusion/exclusion Criteria
Description

Inclusion/exclusion Criteria

Inclusion Criteria
Description

Inclusion Criteria

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ObjectClass-2
C19707
NCI Thesaurus Property
C16112
NCI Thesaurus Property-2
C25532
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1515830
UMLS CUI-2
C1516637
Exclusion Criteria
Description

Exclusion Criteria

Type of Cancer
Description

Type of Cancer

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus Property
C25341
NCI Thesaurus ObjectClass
C9305
UMLS CUI-1
C0872066
Patient HAART regimen type?
Description

Patient HAART regimen type?

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C16165
NCI Thesaurus Property-2
C15697
UMLS CUI-1
C0887947
UMLS CUI-2
C0040808
Karnofsky Performance Status (must be > 60%)
Description

Karnofsky Performance Status (must be > 60%)

Data type

float

Measurement units
  • %
Alias
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C20641
NCI Thesaurus ValueDomain
C25338
UMLS CUI-1
C0206065
%
Age (in years)
Description

Age (in years)

Data type

integer

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ValueDomain
C29848
NCI Thesaurus ValueDomain-2
C25463
NCI Thesaurus Property
C25150
UMLS CUI-1
C2348575
Date Informed Consent Signed (mm/dd/yyyy)
Description

Date Informed Consent Signed (mm/dd/yyyy)

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C16468
NCI Thesaurus Property
C25679
UMLS CUI-1
C0011008
UMLS CUI-2
C0514044
Exclusion Criteria
Description

Exclusion Criteria

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ObjectClass-2
C19707
NCI Thesaurus Property
C16112
NCI Thesaurus Property-2
C25370
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1515830
UMLS CUI-2
C1516637
UMLS CUI-3
C0680251
Consent For Participation In Pharmacogenetics Study And The Use Of Future Tissue Specimens
Description

Consent For Participation In Pharmacogenetics Study And The Use Of Future Tissue Specimens

Does the participant agree to participate in the pharmacogenetics study associated with this protocol
Description

Does the participant agree to participate in the pharmacogenetics study associated with this protocol

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C19157
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C25648
NCI Thesaurus Property-3
C17938
NCI Thesaurus Property-4
C25460
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0586888
UMLS CUI-2
C0243064
Does the participant agree to have excess specimens from this study stored for future AIDS-related research (or leftover)
Description

Does the participant agree to have excess specimens from this study stored for future AIDS-related research (or leftover)

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12801
NCI Thesaurus ObjectClass-2
C12434
NCI Thesaurus ObjectClass-3
C19157
NCI Thesaurus Property
C17649
NCI Thesaurus Property-2
C15319
NCI Thesaurus Property-3
C67527
NCI Thesaurus Property-4
C2991
NCI Thesaurus Property-5
C25460
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0040300
UMLS CUI-2
C0229664
UMLS CUI-3
C0370003
UMLS CUI-4
C1515836
Comments
Description

Comments

Comments
Description

Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS CUI-1
C0282411
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No Instruction available.

1 forms
  1. StudyEvent: AMC-061 Enrollment Form (ENR)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
Projected Begin Date
Item
Projected Start Date of Treatment (mm/dd/yyyy)
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)
C0016538 (UMLS CUI-2)
Item Group
Inclusion/exclusion Criteria
Item
Inclusion Criteria
text
C16960 (NCI Thesaurus ObjectClass)
C19707 (NCI Thesaurus ObjectClass-2)
C16112 (NCI Thesaurus Property)
C25532 (NCI Thesaurus Property-2)
C25284 (NCI Thesaurus ValueDomain)
C1515830 (UMLS CUI-1)
C1516637 (UMLS CUI-2)
CL.1
Code List
Inclusion Criteria
CL Item
Date Informed Consent Obtained (Date informed consent obtained)
C0514044 (UMLS CUI-1)
CL Item
Does The Participant 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 agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug)
C0700589 (UMLS CUI-1)
CL Item
Does The Participant Have A Cd4 Count > 50 Cells/ul (Does the participant have a CD4 count > 50 cells/uL)
C3541261 (UMLS CUI-1)
CL Item
Creatinine Within Institutional Normal Limits Or Glomerular Filtration Rate (gfr) > 60 Ml/min/m^2 (calculated By The Cockcroft-gault Equation) (Creatinine within institutional normal limits or Glomerular filtration rate (GFR) > 60 mL/min/m^2 (calculated by the Cockcroft-Gault equation))
C0428279 (UMLS CUI-1)
CL Item
Does The Participant Have A Histologically Or Cytologically Confirmed Nhl, Biopsy-proven Ks Or Solid Tumor Or Hematological Malignancy (Does the participant have a histologically or cytologically confirmed NHL, biopsy-proven KS or solid tumor or hematological malignancy)
C0024305 (UMLS CUI-1)
C0036220 (UMLS CUI-2)
C0280100 (UMLS CUI-3)
C0376545 (UMLS CUI-4)
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 (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)
C0019693 (UMLS CUI-1)
CL Item
Does The Participant Have The Ability And Willingness To Give Written Informed Consent (Does the participant have the ability and willingness to give written informed consent)
C0811741 (UMLS CUI-1)
CL Item
If The Participant Is Female, And Of Child-bearing Potential, Has She Had A Negative Pregnancy Test Within 72 Hours Before Initiation Of Study Drug Dosing (If the participant is female, and of child-bearing potential, has she had a negative pregnancy test within 72 hours before initiation of study drug dosing)
C1960468 (UMLS CUI-1)
C0427780 (UMLS CUI-2)
CL Item
If Yes, Indicate Cancer Type (see Protocol Section 4.0 For Specific Eligibility Criteria) Nhl, Ks, Renal Cell Cancer, Solid Tumor, Hematologic Malignancy (If Yes, indicate cancer type (see protocol section 4.0 for specific eligibility criteria) NHL, KS, Renal Cell Cancer, Solid tumor, Hematologic malignancy)
C0872066 (UMLS CUI-1)
CL Item
Is The Participant On Stable Anti-retroviral Therapy For At Least 4 Weeks With A Pi-based Or Nnrti-based Regimen Of At Least Three Drugs, With No Intention To Change The Regimen Within 8 Weeks After Starting Study Drug (Is the participant on stable anti-retroviral therapy for at least 4 weeks with a PI-based or NNRTI-based regimen of at least three drugs, with no intention to change the regimen within 8 weeks after starting study drug)
C0887947 (UMLS CUI-1)
CL Item
If Yes, Indicate Haart Regimen Type Nnrti-based Only, Non Ritonavir Pi-based Only, Ritonavir Pi-based Only, Nnrti- And Non Ritonavir Pi-based, Nnrti- And Ritonavir Pi-based, Neither Pi Nor Nnrti Based (If Yes, indicate HAART regimen type NNRTI-based only, Non ritonavir PI-based only, Ritonavir PI-based only, NNRTI- and non ritonavir PI-based, NNRTI- and ritonavir PI-based, Neither PI nor NNRTI based)
C0887947 (UMLS CUI-1)
CL Item
Is The Participant's Life Expectancy 3 Months Or More (Is the participant's life expectancy 3 months or more)
C3845481 (UMLS CUI-1)
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)
C0582783 (UMLS CUI-1)
CL Item
Karnofsky Performance Status (must Be > 60%) (Karnofsky Performance Status (must be > 60%))
C0206065 (UMLS CUI-1)
CL Item
Participant's Age (in Years) (Participant's age (in years))
C0681850 (UMLS CUI-1)
C0001779 (UMLS CUI-2)
CL Item
8.0 gm/dL Absolute neutrophil count (ANC) >= 1500 cells/mm^3 Platelet count >= 100,000 /mm^3=Does The Participant Have The Following Laboratory Parameters Within 7 Days Prior To Study Entry Hemoglobin >= 8.0 Gm/dl Absolute Neutrophil Count (anc) >= 1500 Cells/mm^3 Platelet Count >= 100,000 /mm^3 (Does the participant have the following laboratory parameters within 7 days prior to study entry Hemoglobin >)
C0948762 (UMLS CUI-1)
CL Item
1.5 times ULN (upper limit of normal) (If  (Total bilirubin <)
C0368753 (UMLS CUI-1)
CL Item
1.5 times ULN AST (SGOT) and ALT (SGPT) <= 2.5 times the ULN=(if ((If )
C0004002 (UMLS CUI-1)
C0001899 (UMLS CUI-2)
Item Group
Exclusion Criteria
Item
Type of Cancer
text
C25284 (NCI Thesaurus ValueDomain)
C25341 (NCI Thesaurus Property)
C9305 (NCI Thesaurus ObjectClass)
C0872066 (UMLS CUI-1)
CL.3
Code List
Type of Cancer
CL Item
Non-hodgkin's Lymphoma (Non-Hodgkin's lymphoma)
C3211 (NCI Thesaurus)
C0024305 (UMLS CUI-1)
CL Item
Kaposi Sarcoma (KS)
C9087 (NCI Thesaurus)
C0036220 (UMLS CUI-1)
CL Item
Renal Cell Carcinoma (Renal Cell Cancer)
C9385 (NCI Thesaurus)
C0007134 (UMLS CUI-1)
CL Item
Solid Neoplasm (Solid tumor)
C9292 (NCI Thesaurus)
C0280100 (UMLS CUI-1)
CL Item
Hematologic Malignancy (Hematologic malignancy)
C0376545 (UMLS CUI-1)
Item
Patient HAART regimen type?
text
C25284 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C16165 (NCI Thesaurus Property)
C15697 (NCI Thesaurus Property-2)
C0887947 (UMLS CUI-1)
C0040808 (UMLS CUI-2)
CL.4
Code List
Patient HAART regimen type?
CL Item
Nnrti-based Only (NNRTI-based only)
C3541376 (UMLS CUI-1)
CL Item
Non-ritonavir Pi-based Only (Non-ritonavir PI-based only)
C0033607 (UMLS CUI-1)
C0292818 (UMLS CUI-2)
C1518422 (UMLS CUI-3)
CL Item
Ritonavir Pi-based Only (Ritonavir PI-based only)
C3541376 (UMLS CUI-1)
C3541376 (UMLS CUI-2)
CL Item
Nnrti- And Non-ritonavir Pi-based (NNRTI- and non-ritonavir PI-based)
C3541376 (UMLS CUI-1)
C3541376 (UMLS CUI-2)
C3541376 (UMLS CUI-3)
CL Item
Nnrti- And Ritonavir Pi-based (NNRTI- and ritonavir PI-based)
C3541376 (UMLS CUI-1)
C3541376 (UMLS CUI-2)
CL Item
Neither Pi Nor Nnrti Based (Neither PI nor NNRTI based)
C3541376 (UMLS CUI-1)
C3541376 (UMLS CUI-2)
C3843060 (UMLS CUI-3)
KarnofskyPerformanceStatusScore
Item
Karnofsky Performance Status (must be > 60%)
float
C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0206065 (UMLS CUI-1)
PatientAgeYearCount
Item
Age (in years)
integer
C16960 (NCI Thesaurus ObjectClass)
C29848 (NCI Thesaurus ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C25150 (NCI Thesaurus Property)
C2348575 (UMLS CUI-1)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed (mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C25679 (NCI Thesaurus Property)
C0011008 (UMLS CUI-1)
C0514044 (UMLS CUI-2)
Item
Exclusion Criteria
text
C16960 (NCI Thesaurus ObjectClass)
C19707 (NCI Thesaurus ObjectClass-2)
C16112 (NCI Thesaurus Property)
C25370 (NCI Thesaurus Property-2)
C25284 (NCI Thesaurus ValueDomain)
C1515830 (UMLS CUI-1)
C1516637 (UMLS CUI-2)
C0680251 (UMLS CUI-3)
CL.2
Code List
Exclusion Criteria
CL Item
Does The Participant Have A Concurrent Active Opportunistic Infection (Does the participant have a concurrent active opportunistic infection)
C0029118 (UMLS CUI-1)
CL Item
Does The Participant Have A Pre-existing Thyroid Abnormality That Cannot Be Maintained With Medication To Keep Measures Of Thyroid Stimulating Hormone Within The Normal Range (Does the participant have a pre-existing thyroid abnormality that cannot be maintained with medication to keep measures of thyroid stimulating hormone within the normal range)
C0040128 (UMLS CUI-1)
CL Item
Does The Participant Have A Psychiatric Illness That Would Limit Compliance With Study Requirements (Does the participant have a psychiatric illness that would limit compliance with study requirements)
C0004936 (UMLS CUI-1)
CL Item
Does The Participant Have A Qtc Interval > 500 Msec (Does the participant have a QTc interval > 500 msec)
C1560305 (UMLS CUI-1)
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)
C0973444 (UMLS CUI-1)
C3846017 (UMLS CUI-2)
CL Item
Does The Participant Have Gastrointestinal Tract Disease Resulting In An Inability To Take Oral Medication Or A Requirement For Iv Alimentation, Prior Surgical Procedures Affecting Absorption, Or Active Peptic Ulcer Disease (Does the participant have gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease)
C0017178 (UMLS CUI-1)
CL Item
Does The Participant Have Serious Cardiac Arrhythmia Requiring Medication (Does the participant have serious cardiac arrhythmia requiring medication)
C0003811 (UMLS CUI-1)
CL Item
Has The Participant Had A Myocardial Infarction, Severe/unstable Angina, Coronary Artery Bypass Graft, Cerebrovascular Accident, Transient Ischemic Attack, Or Pulmonary Embolism Within 6 Months Of Study Entry (Has the participant had a myocardial infarction, severe/unstable angina, coronary artery bypass graft, cerebrovascular accident, transient ischemic attack, or pulmonary embolism within 6 months of study entry)
C0027051 (UMLS CUI-1)
CL Item
Does The Participant Have An Abnormal Left Ventricular Ejection Fraction Per Institutional Standards (Does the participant have an abnormal Left Ventricular Ejection Fraction per institutional standards)
C1096403 (UMLS CUI-1)
CL Item
Has The Participant Had Acute Treatment For An Infection Or Other Serious Medical Illness Within 14 Days Prior To Study Entry (Has the participant had acute treatment for an infection or other serious medical illness within 14 days prior to study entry)
C0517783 (UMLS CUI-1)
CL Item
Has The Participant Had Major Surgery Or Radiation Within 3 Weeks Prior To Study Entry (Has the participant had major surgery or radiation within 3 weeks prior to study entry)
C3698433 (UMLS CUI-1)
C0455620 (UMLS CUI-2)
CL Item
Has The Participant Received Antineoplastic Therapy, Including Investigational Drug Or Standard Treatment, Within 2 Weeks Of Study Entry? (must Be Able To Demonstrate Adequate Recovery From Prior Therapy-related Toxicities.) (Has the participant received antineoplastic therapy, including investigational drug or standard treatment, within 2 weeks of study entry? (Must be able to demonstrate adequate recovery from prior therapy-related toxicities.))
C0003392 (UMLS CUI-1)
CL Item
If The Participant Is Female, Is She Pregnant Or Breast-feeding (If the participant is female, is she pregnant or breast-feeding)
C3242212 (UMLS CUI-1)
CL Item
Will The Participant Undergo Concurrent Treatment With Medications, Other Than Antiretroviral Drugs Used To Treat Hiv Infection, That Are Known To Inhibit Or Induce Cyp3a4 (Will the participant undergo concurrent treatment with medications, other than antiretroviral drugs used to treat HIV infection, that are known to inhibit or induce CYP3A4)
C3830625 (UMLS CUI-2)
C3850041 (UMLS CUI-3)
CL Item
3 beats in a row)=Does The Participant Have A History Of Serious Ventricular Arrhythmia (ventricular Tachycardia (vt) Or Ventricular Fibrillation (vf) >= 3 Beats In A Row) (Does the participant have a history of serious ventricular arrhythmia (ventricular tachycardia (VT) or ventricular fibrillation (VF) >)
C0085612 (UMLS CUI-1)
CL Item
2=Does The Participant Have Ongoing Ventricular Cardiac Dysrhythmias Of Nci Ctcae Grade >= 2 (Does the participant have ongoing ventricular cardiac dysrhythmias of NCI CTCAE grade >)
C0003811 (UMLS CUI-1)
C3887242 (UMLS CUI-2)
CL Item
100 mmHg despite optimal medical therapy) or unstable angina=Does The Participant Have Clinically Significant Cardiovascular Disease, Including Uncontrolled Hypertension (diastolic Blood Pressure >=100 Mmhg Despite Optimal Medical Therapy) Or Unstable Angina (Does the participant have clinically significant cardiovascular disease, including uncontrolled hypertension (diastolic blood pressure >)
C0007222 (UMLS CUI-1)
Item Group
Consent For Participation In Pharmacogenetics Study And The Use Of Future Tissue Specimens
Genetic Research Consent
Item
Does the participant agree to participate in the pharmacogenetics study associated with this protocol
boolean
C19157 (NCI Thesaurus ObjectClass)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property-2)
C17938 (NCI Thesaurus Property-3)
C25460 (NCI Thesaurus Property-4)
C38147 (NCI Thesaurus ValueDomain)
C0586888 (UMLS CUI-1)
C0243064 (UMLS CUI-2)
Blood Tissue Future Research Consent
Item
Does the participant agree to have excess specimens from this study stored for future AIDS-related research (or leftover)
boolean
C12801 (NCI Thesaurus ObjectClass)
C12434 (NCI Thesaurus ObjectClass-2)
C19157 (NCI Thesaurus ObjectClass-3)
C17649 (NCI Thesaurus Property)
C15319 (NCI Thesaurus Property-2)
C67527 (NCI Thesaurus Property-3)
C2991 (NCI Thesaurus Property-4)
C25460 (NCI Thesaurus Property-5)
C38147 (NCI Thesaurus ValueDomain)
C0040300 (UMLS CUI-1)
C0229664 (UMLS CUI-2)
C0370003 (UMLS CUI-3)
C1515836 (UMLS CUI-4)
Item Group
Comments
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS CUI-1)
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