ID

11261

Descrizione

AMC Clinical Trials - Eligibility Form for Protocol #042 - PR4201 NCT00090987 Imatinib Mesylate in Treating Patients With HIV-Related Kaposi's Sarcoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EA0B2F9E-96A8-38F4-E034-0003BA3F9857

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EA0B2F9E-96A8-38F4-E034-0003BA3F9857

Keywords

versioni (3)
  1. 19/09/12 19/09/12 -
  2. 09/01/15 09/01/15 - Martin Dugas
  3. 27/06/15 27/06/15 -
Caricato su

27 giugno 2015

DOI

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Creative Commons BY-NC 3.0 Legacy
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AMC Clinical Trials - Eligibility Form for Protocol #042 - PR4201 NCT00090987

Inglese

No Instruction available.

1 moduli  
  1. StudyEvent: AMC Clinical Trials - Eligibility Form for Protocol #042 - PR4201
    1. No Instruction available.
Eligibility Assessment
Descrizione

Eligibility Assessment

Patient Initials
Descrizione

Patient Initials

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient Study ID
Descrizione

Patient Study ID

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Date of Assessment
Descrizione

LesionAssessmentDate

Tipo di dati

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ValueDomain-2
C25367
Is the patient age 18 or older?
Descrizione

PatientAge18YearsIndicator

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (e.g. congestive heart failure, myocardial infarction) within 6 months of study?
Descrizione

PatientNewYorkHeartAssociationClassIII/IVEligibilityDeterminationInd-2

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25171
UMLS 2011AA Property
C0013893
NCI Thesaurus Property-2
C7922
UMLS 2011AA Property-2
C0278962
If the patient is female, is she pregnant or breast-feeding?
Descrizione

FemalePatientNotPregnantIndicator

Tipo di dati

boolean

Does the patient have an acute or known chronic live disease (e.g. chronic active hepatitis, cirrhosis)? Exception: Patients with known Hepatitis C infection but with documentation of no or minimal fibrosis on liver biopsy may be enrolled.
Descrizione

ChronicDiseasePresentInd-3

Tipo di dati

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass-2
C14141
UMLS 2011AA ObjectClass-2
C0205191
Does the patient have biopsy proven KS involving the skin, lymph nodes, oral cavity, gastrointestinal (GI) tract and/or lungs?
Descrizione

DoesthepatienthavebiopsyprovenKSinvolvingtheskin,lymphnodes,oralcavity,gastrointestinal(GI)tractand/orlungs?

Tipo di dati

boolean

Does the patient have at least five measurable, previously non-radiated, cutaneous lesions, which can be used as indicator lesions? Additionally, patient will need three lesions greater or equal to 5 x 5 m that are accessible for 4 mm punch biopsy.
Descrizione

Doesthepatienthaveatleastfivemeasurable,previouslynon-radiated,cutaneouslesions,whichcanbeusedasindicatorlesions?Additionally,patientwillneedthreelesionsgreaterorequalto5x5mthatareaccessiblefor4mmpunchbiopsy.

Tipo di dati

boolean

Does the patient have serologic documentation of HIV infection any time prior to study entry, as evidenced by positive ELISA, positive Western Blot, or other federally approved licensed HIV test?
Descrizione

DoesthepatienthaveserologicdocumentationofHIVinfectionanytimepriortostudyentry,asevidencedbypositiveELISA,positiveWesternBlot,orotherfederallyapprovedlicensedHIVtest?

Tipo di dati

boolean

Is the patient's baseline Karnofsky performance status >= 60%?
Descrizione

Isthepatient'sbaselineKarnofskyperformancestatus>=60%?

Tipo di dati

boolean

If the patient is a female capable of childbearing, has she had a negative pregnancy test within 72 hours before initiation of study drug dosing?
Descrizione

Ifthepatientisafemalecapableofchildbearing,hasshehadanegativepregnancytestwithin72hoursbeforeinitiationofstudydrugdosing?

Tipo di dati

text

If the patient is reproductive potential, does he or she agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug?
Descrizione

Ifthepatientisreproductivepotential,doesheorsheagreetoemployaneffectivebarriermethodofbirthcontrolthroughoutthestudyandforupto3monthsfollowingdiscontinuationofstudydrug?

Tipo di dati

boolean

Is the patient's hemoglobin >= 8 g/dl within 21 days of study entry?
Descrizione

Isthepatient'shemoglobin>=8g/dlwithin21daysofstudyentry?

Tipo di dati

boolean

Is the patient's absolute neutrophil count >= 1000 cells/ mm^3 and platelets >=75,000 cells/mm^3 within 21 days of study entry?
Descrizione

Isthepatient'sabsoluteneutrophilcount>=1000cells/mm^3andplatelets>=75,000cells/mm^3within21daysofstudyentry?

Tipo di dati

boolean

Is the patient's serum creatinine < 1.5 mg/dl or a measured creatinine clearance of > 60 ml/min with 21 days prior to study entry?
Descrizione

Isthepatient'sserumcreatinine<1.5mg/dlorameasuredcreatinineclearanceof>60ml/minwith21dayspriortostudyentry?

Tipo di dati

boolean

Is the patient's total bilirubin normal within 21 days of study entry?
Descrizione

Isthepatient'stotalbilirubinnormalwithin21daysofstudyentry?

Tipo di dati

boolean

Are the patient's AST (SGOT) and ALT (SGPT) <= 2.5 x the upper limit of normal within 21 days of study entry ?
Descrizione

Arethepatient'sAST(SGOT)andALT(SGPT)<=2.5xtheupperlimitofnormalwithin21daysofstudyentry?

Tipo di dati

boolean

Does the patient have a life expectancy of greater than or equal to 3 months?
Descrizione

Doesthepatienthavealifeexpectancyofgreaterthanorequalto3months?

Tipo di dati

boolean

Does the patient have the ability and willingness to give informed consent ?
Descrizione

Doesthepatienthavetheabilityandwillingnesstogiveinformed consent?

Tipo di dati

boolean

In the opinion of the investigator, is the patient capable of complying with this protocol?
Descrizione

Intheopinionoftheinvestigator,isthepatientcapableofcomplyingwiththisprotocol?

Tipo di dati

boolean

Does the patient have no previous imatinib therapy?
Descrizione

Doesthepatienthavenopreviousimatinibtherapy?

Tipo di dati

text

If the patient is a male of child fathering potential, does he agree to practice adequate birth control?
Descrizione

Ifthepatientisamaleofchildfatheringpotential,doesheagreetopracticeadequatebirthcontrol?

Tipo di dati

boolean

Does the patient have a concurrent active opportunistic infection (OI)?
Descrizione

Doesthepatienthaveaconcurrentactiveopportunisticinfection(OI)?

Tipo di dati

boolean

If the patient more than 5 years free of another primary malignancy? Exception: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell cancer or a cervical
Descrizione

Ifthepatientmorethan5yearsfreeofanotherprimarymalignancy?Exception:iftheotherprimarymalignancyisnotcurrentlyclinicallysignificantnorrequiringactiveintervention,orifotherprimarymalignancyisabasalcellcanceroracervical

Tipo di dati

boolean

Does the patient have acute treatment for an infection or other serious medical illness within 14 days prior to study entry?
Descrizione

Doesthepatienthaveacutetreatmentforaninfectionorotherseriousmedicalillnesswithin14dayspriortostudyentry?

Tipo di dati

boolean

Has the patient had anti-neoplastic treatment for Kaposi's Sarcoma (including chemotherapy, radiation therapy, local therapy, biological therapy, or investigational therapy) within 4 weeks (6 weeks for nitrosourea or mitomycin-C) of study entry?
Descrizione

Hasthepatienthadanti-neoplastictreatmentforKaposi'sSarcoma(includingchemotherapy,radiationtherapy,localtherapy,biologicaltherapy,orinvestigationaltherapy)within4weeks(6weeksfornitrosoureaormitomycin-C)ofstudyentry?

Tipo di dati

boolean

Has the patient had previous local therapy of any KS indicator lesion within 60 days (Exception: the lesion has progressed since treatment)?
Descrizione

HasthepatienthadpreviouslocaltherapyofanyKSindicatorlesionwithin60days(Exception:thelesionhasprogressedsincetreatment)?

Tipo di dati

boolean

Does the patient have another severe and/or life-threatening medical disease?
Descrizione

Doesthepatienthaveanothersevereand/orlife-threateningmedicaldisease?

Tipo di dati

boolean

Has the patient had a major surgery within 2 weeks prior to study entry?
Descrizione

Hasthepatienthadamajorsurgerywithin2weekspriortostudyentry?

Tipo di dati

boolean

Is the patient using coumadin and systemic corticosteroid treatment, other than replacement doses?
Descrizione

Isthepatientusingcoumadinandsystemiccorticosteroidtreatment,otherthanreplacementdoses?

Tipo di dati

boolean

Has the patient received granulocyte colony stimulating factor within 2 weeks of study entry?
Descrizione

Hasthepatientreceivedgranulocytecolonystimulatingfactorwithin2weeksofstudyentry?

Tipo di dati

boolean

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Similar models

No Instruction available.

1 moduli
  1. StudyEvent: AMC Clinical Trials - Eligibility Form for Protocol #042 - PR4201
    1. No Instruction available.
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Eligibility Assessment
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient Study ID
Item
Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
LesionAssessmentDate
Item
Date of Assessment
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain-2)
PatientAge18YearsIndicator
Item
Is the patient age 18 or older?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientNewYorkHeartAssociationClassIII/IVEligibilityDeterminationInd-2
Item
Does the patient have Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (e.g. congestive heart failure, myocardial infarction) within 6 months of study?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C7922 (NCI Thesaurus Property-2)
C0278962 (UMLS 2011AA Property-2)
FemalePatientNotPregnantIndicator
Item
If the patient is female, is she pregnant or breast-feeding?
boolean
ChronicDiseasePresentInd-3
Item
Does the patient have an acute or known chronic live disease (e.g. chronic active hepatitis, cirrhosis)? Exception: Patients with known Hepatitis C infection but with documentation of no or minimal fibrosis on liver biopsy may be enrolled.
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C14141 (NCI Thesaurus ObjectClass-2)
C0205191 (UMLS 2011AA ObjectClass-2)
DoesthepatienthavebiopsyprovenKSinvolvingtheskin,lymphnodes,oralcavity,gastrointestinal(GI)tractand/orlungs?
Item
Does the patient have biopsy proven KS involving the skin, lymph nodes, oral cavity, gastrointestinal (GI) tract and/or lungs?
boolean
Doesthepatienthaveatleastfivemeasurable,previouslynon-radiated,cutaneouslesions,whichcanbeusedasindicatorlesions?Additionally,patientwillneedthreelesionsgreaterorequalto5x5mthatareaccessiblefor4mmpunchbiopsy.
Item
Does the patient have at least five measurable, previously non-radiated, cutaneous lesions, which can be used as indicator lesions? Additionally, patient will need three lesions greater or equal to 5 x 5 m that are accessible for 4 mm punch biopsy.
boolean
DoesthepatienthaveserologicdocumentationofHIVinfectionanytimepriortostudyentry,asevidencedbypositiveELISA,positiveWesternBlot,orotherfederallyapprovedlicensedHIVtest?
Item
Does the patient have serologic documentation of HIV infection any time prior to study entry, as evidenced by positive ELISA, positive Western Blot, or other federally approved licensed HIV test?
boolean
Isthepatient'sbaselineKarnofskyperformancestatus>=60%?
Item
Is the patient's baseline Karnofsky performance status >= 60%?
boolean
Item
If the patient is a female capable of childbearing, has she had a negative pregnancy test within 72 hours before initiation of study drug dosing?
text
CL.5
Code List
If the patient is a female capable of childbearing, has she had a negative pregnancy test within 72 hours before initiation of study drug dosing?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
N/A (N/A)
Ifthepatientisreproductivepotential,doesheorsheagreetoemployaneffectivebarriermethodofbirthcontrolthroughoutthestudyandforupto3monthsfollowingdiscontinuationofstudydrug?
Item
If the patient is reproductive potential, does he or she agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug?
boolean
Isthepatient'shemoglobin>=8g/dlwithin21daysofstudyentry?
Item
Is the patient's hemoglobin >= 8 g/dl within 21 days of study entry?
boolean
Isthepatient'sabsoluteneutrophilcount>=1000cells/mm^3andplatelets>=75,000cells/mm^3within21daysofstudyentry?
Item
Is the patient's absolute neutrophil count >= 1000 cells/ mm^3 and platelets >=75,000 cells/mm^3 within 21 days of study entry?
boolean
Isthepatient'sserumcreatinine<1.5mg/dlorameasuredcreatinineclearanceof>60ml/minwith21dayspriortostudyentry?
Item
Is the patient's serum creatinine < 1.5 mg/dl or a measured creatinine clearance of > 60 ml/min with 21 days prior to study entry?
boolean
Isthepatient'stotalbilirubinnormalwithin21daysofstudyentry?
Item
Is the patient's total bilirubin normal within 21 days of study entry?
boolean
Arethepatient'sAST(SGOT)andALT(SGPT)<=2.5xtheupperlimitofnormalwithin21daysofstudyentry?
Item
Are the patient's AST (SGOT) and ALT (SGPT) <= 2.5 x the upper limit of normal within 21 days of study entry ?
boolean
Doesthepatienthavealifeexpectancyofgreaterthanorequalto3months?
Item
Does the patient have a life expectancy of greater than or equal to 3 months?
boolean
Doesthepatienthavetheabilityandwillingnesstogiveinformed consent?
Item
Does the patient have the ability and willingness to give informed consent ?
boolean
Intheopinionoftheinvestigator,isthepatientcapableofcomplyingwiththisprotocol?
Item
In the opinion of the investigator, is the patient capable of complying with this protocol?
boolean
Item
Does the patient have no previous imatinib therapy?
text
CL.16
Code List
Does the patient have no previous imatinib therapy?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
N/A (N/A)
Ifthepatientisamaleofchildfatheringpotential,doesheagreetopracticeadequatebirthcontrol?
Item
If the patient is a male of child fathering potential, does he agree to practice adequate birth control?
boolean
Doesthepatienthaveaconcurrentactiveopportunisticinfection(OI)?
Item
Does the patient have a concurrent active opportunistic infection (OI)?
boolean
Ifthepatientmorethan5yearsfreeofanotherprimarymalignancy?Exception:iftheotherprimarymalignancyisnotcurrentlyclinicallysignificantnorrequiringactiveintervention,orifotherprimarymalignancyisabasalcellcanceroracervical
Item
If the patient more than 5 years free of another primary malignancy? Exception: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell cancer or a cervical
boolean
Doesthepatienthaveacutetreatmentforaninfectionorotherseriousmedicalillnesswithin14dayspriortostudyentry?
Item
Does the patient have acute treatment for an infection or other serious medical illness within 14 days prior to study entry?
boolean
Hasthepatienthadanti-neoplastictreatmentforKaposi'sSarcoma(includingchemotherapy,radiationtherapy,localtherapy,biologicaltherapy,orinvestigationaltherapy)within4weeks(6weeksfornitrosoureaormitomycin-C)ofstudyentry?
Item
Has the patient had anti-neoplastic treatment for Kaposi's Sarcoma (including chemotherapy, radiation therapy, local therapy, biological therapy, or investigational therapy) within 4 weeks (6 weeks for nitrosourea or mitomycin-C) of study entry?
boolean
HasthepatienthadpreviouslocaltherapyofanyKSindicatorlesionwithin60days(Exception:thelesionhasprogressedsincetreatment)?
Item
Has the patient had previous local therapy of any KS indicator lesion within 60 days (Exception: the lesion has progressed since treatment)?
boolean
Doesthepatienthaveanothersevereand/orlife-threateningmedicaldisease?
Item
Does the patient have another severe and/or life-threatening medical disease?
boolean
Hasthepatienthadamajorsurgerywithin2weekspriortostudyentry?
Item
Has the patient had a major surgery within 2 weeks prior to study entry?
boolean
Isthepatientusingcoumadinandsystemiccorticosteroidtreatment,otherthanreplacementdoses?
Item
Is the patient using coumadin and systemic corticosteroid treatment, other than replacement doses?
boolean
Hasthepatientreceivedgranulocytecolonystimulatingfactorwithin2weeksofstudyentry?
Item
Has the patient received granulocyte colony stimulating factor within 2 weeks of study entry?
boolean
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