ID

3153

Descrizione

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

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 -
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19 settembre 2012

DOI

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Sarcoma NCT00090987 Eligibility - AMC Clinical Trials - Eligibility Form for Protocol #042 - PR4201 - 2264624v3.0

Inglese

No Instruction available.

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

Unnamed 1

Patient Initials
Descrizione

PatientInitialsName

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
Patient Study ID
Descrizione

PatientCoordinatingIdentifierNumber

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25462
UMLS 2011AA Property
C0700114
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
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
C25367
Is the patient age 18 or older?
Descrizione

PatientAge18YearsIndicator

Tipo di dati

text

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

text

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
C7922
UMLS 2011AA Property
C0278962
If the patient is female, is she pregnant or breast-feeding?
Descrizione

FemalePatientNotPregnantIndicator

Tipo di dati

text

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

text

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
C14141
UMLS 2011AA ObjectClass
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

text

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

text

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

text

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

Isthepatient'sbaselineKarnofskyperformancestatus>=60%?

Tipo di dati

text

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

text

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

Isthepatient'shemoglobin>=8g/dlwithin21daysofstudyentry?

Tipo di dati

text

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

text

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

text

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

Isthepatient'stotalbilirubinnormalwithin21daysofstudyentry?

Tipo di dati

text

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

text

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

Doesthepatienthavealifeexpectancyofgreaterthanorequalto3months?

Tipo di dati

text

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

Doesthepatienthavetheabilityandwillingnesstogiveinformed consent?

Tipo di dati

text

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

Intheopinionoftheinvestigator,isthepatientcapableofcomplyingwiththisprotocol?

Tipo di dati

text

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

text

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

Doesthepatienthaveaconcurrentactiveopportunisticinfection(OI)?

Tipo di dati

text

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

text

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

text

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

text

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

text

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

Doesthepatienthaveanothersevereand/orlife-threateningmedicaldisease?

Tipo di dati

text

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

Hasthepatienthadamajorsurgerywithin2weekspriortostudyentry?

Tipo di dati

text

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

Isthepatientusingcoumadinandsystemiccorticosteroidtreatment,otherthanreplacementdoses?

Tipo di dati

text

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

Hasthepatientreceivedgranulocytecolonystimulatingfactorwithin2weeksofstudyentry?

Tipo di dati

text

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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
Unnamed 1
PatientInitialsName
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
PatientCoordinatingIdentifierNumber
Item
Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25462 (NCI Thesaurus Property)
C0700114 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
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)
Item
Is the patient age 18 or older?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.13
Code List
Is the patient age 18 or older?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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?
text
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)
C0278962 (UMLS 2011AA Property)
CL.23
Code List
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?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
If the patient is female, is she pregnant or breast-feeding?
text
CL.24
Code List
If the patient is female, is she pregnant or breast-feeding?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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.
text
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)
C0205191 (UMLS 2011AA ObjectClass)
CL.26
Code List
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.
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Does the patient have biopsy proven KS involving the skin, lymph nodes, oral cavity, gastrointestinal (GI) tract and/or lungs?
text
CL.1
Code List
Does the patient have biopsy proven KS involving the skin, lymph nodes, oral cavity, gastrointestinal (GI) tract and/or lungs?
CL Item
Yes (Yes)
CL Item
No (No)
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.
text
CL.2
Code List
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.
CL Item
Yes (Yes)
CL Item
No (No)
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?
text
CL.3
Code List
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?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is the patient's baseline Karnofsky performance status >= 60%?
text
CL.4
Code List
Is the patient's baseline Karnofsky performance status >= 60%?
CL Item
Yes (Yes)
CL Item
No (No)
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)
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?
text
CL.6
Code List
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?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is the patient's hemoglobin >= 8 g/dl within 21 days of study entry?
text
CL.7
Code List
Is the patient's hemoglobin >= 8 g/dl within 21 days of study entry?
CL Item
Yes (Yes)
CL Item
No (No)
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?
text
CL.8
Code List
Is the patient's absolute neutrophil count >= 1000 cells/ mm^3 and platelets >=75,000 cells/mm^3 within 21 days of study entry?
CL Item
Yes (Yes)
CL Item
No (No)
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?
text
CL.9
Code List
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?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is the patient's total bilirubin normal within 21 days of study entry?
text
CL.10
Code List
Is the patient's total bilirubin normal within 21 days of study entry?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Are the patient's AST (SGOT) and ALT (SGPT) <= 2.5 x the upper limit of normal within 21 days of study entry ?
text
CL.11
Code List
Are the patient's AST (SGOT) and ALT (SGPT) <= 2.5 x the upper limit of normal within 21 days of study entry ?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does the patient have a life expectancy of greater than or equal to 3 months?
text
CL.12
Code List
Does the patient have a life expectancy of greater than or equal to 3 months?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does the patient have the ability and willingness to give informed consent ?
text
CL.14
Code List
Does the patient have the ability and willingness to give informed consent ?
CL Item
Yes (Yes)
CL Item
No (No)
Item
In the opinion of the investigator, is the patient capable of complying with this protocol?
text
CL.15
Code List
In the opinion of the investigator, is the patient capable of complying with this protocol?
CL Item
Yes (Yes)
CL Item
No (No)
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)
Item
If the patient is a male of child fathering potential, does he agree to practice adequate birth control?
text
CL.17
Code List
If the patient is a male of child fathering potential, does he agree to practice adequate birth control?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does the patient have a concurrent active opportunistic infection (OI)?
text
CL.18
Code List
Does the patient have a concurrent active opportunistic infection (OI)?
CL Item
Yes (Yes)
CL Item
No (No)
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
text
CL.19
Code List
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
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does the patient have acute treatment for an infection or other serious medical illness within 14 days prior to study entry?
text
CL.20
Code List
Does the patient have acute treatment for an infection or other serious medical illness within 14 days prior to study entry?
CL Item
Yes (Yes)
CL Item
No (No)
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?
text
CL.21
Code List
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?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Has the patient had previous local therapy of any KS indicator lesion within 60 days (Exception: the lesion has progressed since treatment)?
text
CL.22
Code List
Has the patient had previous local therapy of any KS indicator lesion within 60 days (Exception: the lesion has progressed since treatment)?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does the patient have another severe and/or life-threatening medical disease?
text
CL.25
Code List
Does the patient have another severe and/or life-threatening medical disease?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Has the patient had a major surgery within 2 weeks prior to study entry?
text
CL.27
Code List
Has the patient had a major surgery within 2 weeks prior to study entry?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is the patient using coumadin and systemic corticosteroid treatment, other than replacement doses?
text
CL.28
Code List
Is the patient using coumadin and systemic corticosteroid treatment, other than replacement doses?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Has the patient received granulocyte colony stimulating factor within 2 weeks of study entry?
text
CL.29
Code List
Has the patient received granulocyte colony stimulating factor within 2 weeks of study entry?
CL Item
Yes (Yes)
CL Item
No (No)
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