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Erreur:
ID
3153
Description
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
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Mots-clés
Versions (3)
- 19/09/2012 19/09/2012 -
- 09/01/2015 09/01/2015 - Martin Dugas
- 27/06/2015 27/06/2015 -
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19 septembre 2012
DOI
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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
No Instruction available.
- StudyEvent: AMC Clinical Trials - Eligibility Form for Protocol #042 - PR4201
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- StudyEvent: AMC Clinical Trials - Eligibility Form for Protocol #042 - PR4201
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
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)
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)
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)
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)
C1512698 (UMLS 2011AA ValueDomain)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
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)
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)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C1298908 (UMLS 2011AA)
Item
If the patient is female, is she pregnant or breast-feeding?
text
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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)
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)
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)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
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
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
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
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 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
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
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 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
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
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 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
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 Item
Yes (Yes)
CL Item
No (No)
Item
Does the patient have the ability and willingness to give informed consent ?
text
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
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 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
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 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
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
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
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
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 Item
Yes (Yes)
CL Item
No (No)
Item
Has the patient had a major surgery within 2 weeks prior to study entry?
text
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is the patient using coumadin and systemic corticosteroid treatment, other than replacement doses?
text
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
Code List
Has the patient received granulocyte colony stimulating factor within 2 weeks of study entry?
CL Item
Yes (Yes)
CL Item
No (No)