ID

3153

Beschrijving

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

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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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19 september 2012

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

Engels

No Instruction available.

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

Unnamed 1

Patient Initials
Beschrijving

PatientInitialsName

Datatype

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
Beschrijving

PatientCoordinatingIdentifierNumber

Datatype

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
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
C25367
Is the patient age 18 or older?
Beschrijving

PatientAge18YearsIndicator

Datatype

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?
Beschrijving

PatientNewYorkHeartAssociationClassIII/IVEligibilityDeterminationInd-2

Datatype

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?
Beschrijving

FemalePatientNotPregnantIndicator

Datatype

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.
Beschrijving

ChronicDiseasePresentInd-3

Datatype

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?
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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?
Beschrijving

DoesthepatienthaveserologicdocumentationofHIVinfectionanytimepriortostudyentry,asevidencedbypositiveELISA,positiveWesternBlot,orotherfederallyapprovedlicensedHIVtest?

Datatype

text

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

Isthepatient'sbaselineKarnofskyperformancestatus>=60%?

Datatype

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?
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

text

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

Isthepatient'shemoglobin>=8g/dlwithin21daysofstudyentry?

Datatype

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?
Beschrijving

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

Datatype

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?
Beschrijving

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

Datatype

text

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

Isthepatient'stotalbilirubinnormalwithin21daysofstudyentry?

Datatype

text

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

text

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

Doesthepatienthavealifeexpectancyofgreaterthanorequalto3months?

Datatype

text

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

Doesthepatienthavetheabilityandwillingnesstogiveinformed consent?

Datatype

text

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

Intheopinionoftheinvestigator,isthepatientcapableofcomplyingwiththisprotocol?

Datatype

text

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

text

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

Doesthepatienthaveaconcurrentactiveopportunisticinfection(OI)?

Datatype

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
Beschrijving

Ifthepatientmorethan5yearsfreeofanotherprimarymalignancy?Exception:iftheotherprimarymalignancyisnotcurrentlyclinicallysignificantnorrequiringactiveintervention,orifotherprimarymalignancyisabasalcellcanceroracervical

Datatype

text

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

Doesthepatienthaveacutetreatmentforaninfectionorotherseriousmedicalillnesswithin14dayspriortostudyentry?

Datatype

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?
Beschrijving

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

Datatype

text

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

text

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

Doesthepatienthaveanothersevereand/orlife-threateningmedicaldisease?

Datatype

text

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

Hasthepatienthadamajorsurgerywithin2weekspriortostudyentry?

Datatype

text

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

Isthepatientusingcoumadinandsystemiccorticosteroidtreatment,otherthanreplacementdoses?

Datatype

text

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

Hasthepatientreceivedgranulocytecolonystimulatingfactorwithin2weeksofstudyentry?

Datatype

text

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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
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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