ID

11626

Description

AMC-061 Enrollment Form (ENR) 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

Lien

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

Mots-clés

C71

D016430

Registration

Central Nervous System Neoplasms

Téléchargé le

8 juillet 2015

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0 Legacy

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AMC-061 Enrollment Form (ENR)

model
Détails

No Instruction available.

1 Formulaires

StudyEvent: AMC-061 Enrollment Form (ENR)
1. No Instruction available.

Name

Type

Description | Question | Decode (Coded Value)

Type de données

Alias

Header Module

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)

Inclusion Criteria

Item Group

Inclusion/exclusion Criteria

AIDS Malignancy Consortium Patient Inclusion ClinicalTrialEligibility

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)

Exclusion Criteria

Item Group

Exclusion Criteria

CancerSiteType

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)

Patient HAART regimen type?

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)

Patient Exclusion Eligibility Criteria

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)

Consent For Participation in Pharmacogenetics Study and The Use Of Future Tissue Specimens

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)

Comments

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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Lien

Mots-clés

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AMC-061 Enrollment Form (ENR)

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