ID

11261

Beschrijving

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

Link

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

Trefwoorden

Versies (3)
  1. 19-09-12 19-09-12 -
  2. 09-01-15 09-01-15 - Martin Dugas
  3. 27-06-15 27-06-15 -
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27 juni 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

Engels

No Instruction available.

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

Eligibility Assessment

Patient Initials
Beschrijving

Patient Initials

Datatype

text

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

Patient Study ID

Datatype

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
Beschrijving

LesionAssessmentDate

Datatype

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?
Beschrijving

PatientAge18YearsIndicator

Datatype

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?
Beschrijving

PatientNewYorkHeartAssociationClassIII/IVEligibilityDeterminationInd-2

Datatype

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?
Beschrijving

FemalePatientNotPregnantIndicator

Datatype

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.
Beschrijving

ChronicDiseasePresentInd-3

Datatype

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?
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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?
Beschrijving

DoesthepatienthaveserologicdocumentationofHIVinfectionanytimepriortostudyentry,asevidencedbypositiveELISA,positiveWesternBlot,orotherfederallyapprovedlicensedHIVtest?

Datatype

boolean

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

Isthepatient'sbaselineKarnofskyperformancestatus>=60%?

Datatype

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?
Beschrijving

Ifthepatientisafemalecapableofchildbearing,hasshehadanegativepregnancytestwithin72hoursbeforeinitiationofstudydrugdosing?

Datatype

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?
Beschrijving

Ifthepatientisreproductivepotential,doesheorsheagreetoemployaneffectivebarriermethodofbirthcontrolthroughoutthestudyandforupto3monthsfollowingdiscontinuationofstudydrug?

Datatype

boolean

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

Isthepatient'shemoglobin>=8g/dlwithin21daysofstudyentry?

Datatype

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?
Beschrijving

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

Datatype

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?
Beschrijving

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

Datatype

boolean

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

Isthepatient'stotalbilirubinnormalwithin21daysofstudyentry?

Datatype

boolean

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

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

Datatype

boolean

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

Doesthepatienthavealifeexpectancyofgreaterthanorequalto3months?

Datatype

boolean

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

Doesthepatienthavetheabilityandwillingnesstogiveinformed consent?

Datatype

boolean

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

Intheopinionoftheinvestigator,isthepatientcapableofcomplyingwiththisprotocol?

Datatype

boolean

Does the patient have no previous imatinib therapy?
Beschrijving

Doesthepatienthavenopreviousimatinibtherapy?

Datatype

text

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

Ifthepatientisamaleofchildfatheringpotential,doesheagreetopracticeadequatebirthcontrol?

Datatype

boolean

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

Doesthepatienthaveaconcurrentactiveopportunisticinfection(OI)?

Datatype

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
Beschrijving

Ifthepatientmorethan5yearsfreeofanotherprimarymalignancy?Exception:iftheotherprimarymalignancyisnotcurrentlyclinicallysignificantnorrequiringactiveintervention,orifotherprimarymalignancyisabasalcellcanceroracervical

Datatype

boolean

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

Doesthepatienthaveacutetreatmentforaninfectionorotherseriousmedicalillnesswithin14dayspriortostudyentry?

Datatype

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?
Beschrijving

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

Datatype

boolean

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

HasthepatienthadpreviouslocaltherapyofanyKSindicatorlesionwithin60days(Exception:thelesionhasprogressedsincetreatment)?

Datatype

boolean

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

Doesthepatienthaveanothersevereand/orlife-threateningmedicaldisease?

Datatype

boolean

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

Hasthepatienthadamajorsurgerywithin2weekspriortostudyentry?

Datatype

boolean

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

Isthepatientusingcoumadinandsystemiccorticosteroidtreatment,otherthanreplacementdoses?

Datatype

boolean

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

Hasthepatientreceivedgranulocytecolonystimulatingfactorwithin2weeksofstudyentry?

Datatype

boolean

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Similar models

No Instruction available.

1 Formulieren
  1. StudyEvent: AMC Clinical Trials - Eligibility Form for Protocol #042 - PR4201
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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