ID

8594

Descrição

AMC Clinical Trials - Eligibility Form for Protocol #042 - PR4201 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

Palavras-chave

Versões (3)
  1. 19/09/2012 19/09/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
  3. 27/06/2015 27/06/2015 -
Transferido a

9 de janeiro de 2015

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy
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Sarcoma NCT00090987 Eligibility - AMC Clinical Trials - Eligibility Form for Protocol #042 - PR4201 - 2264624v3.0

Inglês

No Instruction available.

1 Formulários  
  1. StudyEvent: AMC Clinical Trials - Eligibility Form for Protocol #042 - PR4201
    1. No Instruction available.
Unnamed 1
Descrição

Unnamed 1

Patient Initials
Descrição

Patient Initials

Tipo de dados

text

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

Patient Study ID

Tipo de dados

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
Descrição

LesionAssessmentDate

Tipo de dados

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?
Descrição

PatientAge18YearsIndicator

Tipo de dados

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?
Descrição

PatientNewYorkHeartAssociationClassIII/IVEligibilityDeterminationInd-2

Tipo de dados

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?
Descrição

FemalePatientNotPregnantIndicator

Tipo de dados

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.
Descrição

ChronicDiseasePresentInd-3

Tipo de dados

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?
Descrição

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

Tipo de dados

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.
Descrição

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

Tipo de dados

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?
Descrição

DoesthepatienthaveserologicdocumentationofHIVinfectionanytimepriortostudyentry,asevidencedbypositiveELISA,positiveWesternBlot,orotherfederallyapprovedlicensedHIVtest?

Tipo de dados

boolean

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

Isthepatient'sbaselineKarnofskyperformancestatus>=60%?

Tipo de dados

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?
Descrição

Ifthepatientisafemalecapableofchildbearing,hasshehadanegativepregnancytestwithin72hoursbeforeinitiationofstudydrugdosing?

Tipo de dados

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?
Descrição

Ifthepatientisreproductivepotential,doesheorsheagreetoemployaneffectivebarriermethodofbirthcontrolthroughoutthestudyandforupto3monthsfollowingdiscontinuationofstudydrug?

Tipo de dados

boolean

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

Isthepatient'shemoglobin>=8g/dlwithin21daysofstudyentry?

Tipo de dados

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?
Descrição

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

Tipo de dados

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?
Descrição

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

Tipo de dados

boolean

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

Isthepatient'stotalbilirubinnormalwithin21daysofstudyentry?

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

Doesthepatienthavealifeexpectancyofgreaterthanorequalto3months?

Tipo de dados

boolean

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

Doesthepatienthavetheabilityandwillingnesstogiveinformed consent?

Tipo de dados

boolean

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

Intheopinionoftheinvestigator,isthepatientcapableofcomplyingwiththisprotocol?

Tipo de dados

boolean

Does the patient have no previous imatinib therapy?
Descrição

Doesthepatienthavenopreviousimatinibtherapy?

Tipo de dados

text

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

Ifthepatientisamaleofchildfatheringpotential,doesheagreetopracticeadequatebirthcontrol?

Tipo de dados

boolean

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

Doesthepatienthaveaconcurrentactiveopportunisticinfection(OI)?

Tipo de dados

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
Descrição

Ifthepatientmorethan5yearsfreeofanotherprimarymalignancy?Exception:iftheotherprimarymalignancyisnotcurrentlyclinicallysignificantnorrequiringactiveintervention,orifotherprimarymalignancyisabasalcellcanceroracervical

Tipo de dados

boolean

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

Doesthepatienthaveacutetreatmentforaninfectionorotherseriousmedicalillnesswithin14dayspriortostudyentry?

Tipo de dados

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?
Descrição

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

Tipo de dados

boolean

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

HasthepatienthadpreviouslocaltherapyofanyKSindicatorlesionwithin60days(Exception:thelesionhasprogressedsincetreatment)?

Tipo de dados

boolean

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

Doesthepatienthaveanothersevereand/orlife-threateningmedicaldisease?

Tipo de dados

boolean

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

Hasthepatienthadamajorsurgerywithin2weekspriortostudyentry?

Tipo de dados

boolean

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

Isthepatientusingcoumadinandsystemiccorticosteroidtreatment,otherthanreplacementdoses?

Tipo de dados

boolean

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

Hasthepatientreceivedgranulocytecolonystimulatingfactorwithin2weeksofstudyentry?

Tipo de dados

boolean

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Similar models

No Instruction available.

1 Formulários
  1. StudyEvent: AMC Clinical Trials - Eligibility Form for Protocol #042 - PR4201
    1. No Instruction available.
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Unnamed 1
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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