ID

11262

Description

AMC Clinical Trials - Eligibility Form for Protocol #038 - PR3801 NCT00075777 Valproic Acid in Treating Patients With Kaposi's Sarcoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DB418191-47FB-4C91-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DB418191-47FB-4C91-E034-0003BA12F5E7

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 6/27/15 6/27/15 -
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June 27, 2015

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Creative Commons BY-NC 3.0 Legacy
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AMC Clinical Trials - Eligibility Form for Protocol #038 - PR3801 NCT00075777

English

No Instruction available.

1 forms  
  1. StudyEvent: AMC Clinical Trials - Eligibility Form for Protocol #038 - PR3801
    1. No Instruction available.
Eligibility Assessment
Description

Eligibility Assessment

Patient Initials
Description

Patient Initials

Data type

text

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

Patient Study ID

Data type

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
Description

Dateofassessment

Data type

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 viral load determination?
Description

TransplantPatientHumanImmunodeficiencyVirusAntibodyInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C12981
UMLS 2011AA ObjectClass-2
C0332835
NCI Thesaurus Property
C14219
UMLS 2011AA Property
C0019682
NCI Thesaurus Property-2
C16295
UMLS 2011AA Property-2
C0003241
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
the patient's life expectancy >= 3 months?
Description

PatientLifeExpectancyEligibilityDeterminationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C37987
UMLS 2011AA Property
C0376558
NCI Thesaurus Property-2
C25171
UMLS 2011AA Property-2
C0013893
NCI Thesaurus Property-3
C25359
UMLS 2011AA Property-3
C0679138
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Is the patient age 18 or older?
Description

PatientAge18YearsIndicator

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Does the patient have biopsy proven KS involving the skin and /or lymph nodes, HIV related, not requiring systemic treatment (radiation or chemotherapy) less than 2 weeks before enrollment?
Description

DoesthepatienthavebiopsyprovenKSinvolvingtheskinand/orlymphnodes,HIVrelated,notrequiringsystemictreatment(radiationorchemotherapy)lessthan2weeksbeforeenrollment?

Data type

boolean

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

Isthepatient'sbaselineKarnofskyperformancestatus>=60%?

Data type

boolean

Is the patient's hemoglobin >= 8 g/dl within 14 days of study entry?
Description

Isthepatient'shemoglobin>=8g/dlwithin14daysofstudyentry?

Data type

boolean

Is the patient's absolute neutrophil count >= 750 cells/ mm and platelets >=5,000 cells/mm within 14 days of study entry?
Description

Isthepatient'sabsoluteneutrophilcount>=750cells/mmandplatelets >=5,000cells/mmwithin14daysofstudyentry?

Data type

boolean

Is the patient's serum creatinine < 1.5 times the upper limit of normal within 14 days of study entry?
Description

Isthepatient'sserumcreatinine<1.5timestheupperlimitofnormalwithin14daysofstudyentry?

Data type

boolean

Is the patient's total bilirubin <=1.5x ULN within 14 days of study entry? If not, is the patient's total bilirubin <= 3.5 mg/dl with a normal direct bilirubin, and is the elevated bilirubin thought to be secondary to Indinavir therapy?
Description

Isthepatient'stotalbilirubin<=1.5xULNwithin14daysofstudyentry? Ifnot,isthepatient'stotalbilirubin<=3.5mg/dlwithanormaldirect bilirubin,andistheelevatedbilirubinthoughttobesecondarytoIndinavirtherapy?

Data type

boolean

Are the patient's AST (SGOT) and ALT (SGPT) <= 3 x the upper limit of normal within 14 days of study entry ?
Description

Arethepatient'sAST(SGOT)andALT(SGPT)<=3xtheupperlimitofnormalwithin14daysofstudyentry?

Data type

boolean

Is the patient's albumin > 2.5?
Description

Isthepatient'salbumin>2.5?

Data type

boolean

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

Doesthepatienthavetheabilityandwillingnesstogiveinformed consent?

Data type

boolean

If the patient is a female capable of childbearing, has she had a negative serum beta-HCG within 72 hours prior to study entry?
Description

Ifthepatientisafemalecapableofchildbearing,hasshehada negativeserumbeta-HCGwithin72hourspriortostudyentry?

Data type

text

If the patient is a female capable of childbearing , does she agree to practice adequate birth control to prevent pregnancy while receiving treatment and for three months after treatment is discontinued?
Description

Ifthepatientisafemalecapableofchildbearing,doessheagree topracticeadequatebirthcontroltopreventpregnancywhile receivingtreatmentandforthreemonthsaftertreatmentis discontinued?

Data type

text

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

Ifthepatientisamaleofchildfatheringpotential,doesheagreetopracticeadequatebirthcontrol?

Data type

text

Is the patient capable of complying with the protocol?
Description

Isthepatientcapableofcomplyingwiththeprotocol?

Data type

boolean

If the patient is receiving antiretroviral therapy, has the patient been on a stable regimen for at least 4 weeks prior to study entry? Patients may receive any FDA approved antiretroviral therapy or agents available through a treatment IND, except regime
Description

Ifthepatientisreceivingantiretroviraltherapy,hasthepatientbeenonastableregimenforatleast4weekspriortostudyentry?PatientsmayreceiveanyFDAapprovedantiretroviraltherapyoragentsavailablethroughatreatmentIND,exceptregime

Data type

boolean

Has the patient had a concurrent, acute, active opportunistic infection other than oral thrush or genital herpes within 14 days of enrollment?
Description

Hasthepatienthadaconcurrent,acute,activeopportunisticinfection otherthanoralthrushorgenitalherpeswithin14daysofenrollment?

Data type

boolean

Does the patient have visceral Kaposi's Sarcoma?
Description

DoesthepatienthavevisceralKaposi'sSarcoma?

Data type

boolean

Does the patient have oral Kaposi's sarcoma as the only site of disease?
Description

DoesthepatienthaveoralKaposi'ssarcomaastheonlysiteofdisease?

Data type

boolean

Does the patient have a concurrent neoplasm requiring cytotoxic therapy?
Description

Doesthepatienthaveaconcurrentneoplasmrequiringcytotoxictherapy?

Data type

boolean

Has the patient had anti-neoplastic treatment for Kaposi's Sarcoma (including chemotherapy, radiation therapy, local therapy, biological therapy, or investigational therapy) within two weeks of study entry?
Description

Hasthepatienthadanti-neoplastictreatmentforKaposi'sSarcoma (includingchemotherapy,radiationtherapy,localtherapy,biological therapy,orinvestigationaltherapy)withintwoweeksofstudyentry?

Data type

boolean

Has the patient had previous local therapy of any KS-marker lesion within 60 days (Exception: the lesion has clearly progressed since treatment)?
Description

HasthepatienthadpreviouslocaltherapyofanyKS-markerlesion within60days(Exception:thelesionhasclearlyprogressedsince treatment)?

Data type

boolean

Has the patient used investigational agents other than antiretroviral drugs available under expanded access or compassionate use protocols?
Description

Hasthepatientusedinvestigationalagentsotherthanantiretroviral drugsavailableunderexpandedaccessorcompassionateuseprotocols?

Data type

boolean

Does the patient have a history of valproic acid or valproate use in the previous year?
Description

Doesthepatienthaveahistoryofvalproicacidorvalproateuseinthe previousyear?

Data type

boolean

Does the patient have evidence of a prior MI or cardiac ischemia?
Description

DoesthepatienthaveevidenceofapriorMIorcardiacischemia?

Data type

boolean

Is the patient using AZT ?
Description

IsthepatientusingAZT?

Data type

boolean

Does the patient have a history of lactic acidosis greater than 2 mmoles / liter?
Description

Doesthepatienthaveahistoryoflacticacidosisgreaterthan 2mmoles/liter?

Data type

boolean

Does the patient have a history of lipoatrophy or hypercholesterolemia secondary to retroviral treatment?
Description

Doesthepatienthaveahistoryoflipoatrophyorhypercholesterolemia secondarytoretroviraltreatment?

Data type

boolean

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Similar models

No Instruction available.

1 forms
  1. StudyEvent: AMC Clinical Trials - Eligibility Form for Protocol #038 - PR3801
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
Dateofassessment
Item
Date of Assessment
text
TransplantPatientHumanImmunodeficiencyVirusAntibodyInd-3
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 viral load determination?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12981 (NCI Thesaurus ObjectClass-2)
C0332835 (UMLS 2011AA ObjectClass-2)
C14219 (NCI Thesaurus Property)
C0019682 (UMLS 2011AA Property)
C16295 (NCI Thesaurus Property-2)
C0003241 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PatientLifeExpectancyEligibilityDeterminationInd-2
Item
the patient's life expectancy >= 3 months?
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C37987 (NCI Thesaurus Property)
C0376558 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property-2)
C0013893 (UMLS 2011AA Property-2)
C25359 (NCI Thesaurus Property-3)
C0679138 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientAge18YearsIndicator
Item
Is the patient age 18 or older?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
DoesthepatienthavebiopsyprovenKSinvolvingtheskinand/orlymphnodes,HIVrelated,notrequiringsystemictreatment(radiationorchemotherapy)lessthan2weeksbeforeenrollment?
Item
Does the patient have biopsy proven KS involving the skin and /or lymph nodes, HIV related, not requiring systemic treatment (radiation or chemotherapy) less than 2 weeks before enrollment?
boolean
Isthepatient'sbaselineKarnofskyperformancestatus>=60%?
Item
Is the patient's baseline Karnofsky performance status >= 60%?
boolean
Isthepatient'shemoglobin>=8g/dlwithin14daysofstudyentry?
Item
Is the patient's hemoglobin >= 8 g/dl within 14 days of study entry?
boolean
Isthepatient'sabsoluteneutrophilcount>=750cells/mmandplatelets >=5,000cells/mmwithin14daysofstudyentry?
Item
Is the patient's absolute neutrophil count >= 750 cells/ mm and platelets >=5,000 cells/mm within 14 days of study entry?
boolean
Isthepatient'sserumcreatinine<1.5timestheupperlimitofnormalwithin14daysofstudyentry?
Item
Is the patient's serum creatinine < 1.5 times the upper limit of normal within 14 days of study entry?
boolean
Isthepatient'stotalbilirubin<=1.5xULNwithin14daysofstudyentry? Ifnot,isthepatient'stotalbilirubin<=3.5mg/dlwithanormaldirect bilirubin,andistheelevatedbilirubinthoughttobesecondarytoIndinavirtherapy?
Item
Is the patient's total bilirubin <=1.5x ULN within 14 days of study entry? If not, is the patient's total bilirubin <= 3.5 mg/dl with a normal direct bilirubin, and is the elevated bilirubin thought to be secondary to Indinavir therapy?
boolean
Arethepatient'sAST(SGOT)andALT(SGPT)<=3xtheupperlimitofnormalwithin14daysofstudyentry?
Item
Are the patient's AST (SGOT) and ALT (SGPT) <= 3 x the upper limit of normal within 14 days of study entry ?
boolean
Isthepatient'salbumin>2.5?
Item
Is the patient's albumin > 2.5?
boolean
Doesthepatienthavetheabilityandwillingnesstogiveinformed consent?
Item
Does the patient have the ability and willingness to give informed consent ?
boolean
Item
If the patient is a female capable of childbearing, has she had a negative serum beta-HCG within 72 hours prior to study entry?
text
CL.13
Code List
If the patient is a female capable of childbearing, has she had a negative serum beta-HCG within 72 hours prior to study entry?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
N/A (N/A)
Item
If the patient is a female capable of childbearing , does she agree to practice adequate birth control to prevent pregnancy while receiving treatment and for three months after treatment is discontinued?
text
CL.14
Code List
If the patient is a female capable of childbearing , does she agree to practice adequate birth control to prevent pregnancy while receiving treatment and for three months after treatment is discontinued?
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.15
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)
CL Item
N/A (N/A)
Isthepatientcapableofcomplyingwiththeprotocol?
Item
Is the patient capable of complying with the protocol?
boolean
Ifthepatientisreceivingantiretroviraltherapy,hasthepatientbeenonastableregimenforatleast4weekspriortostudyentry?PatientsmayreceiveanyFDAapprovedantiretroviraltherapyoragentsavailablethroughatreatmentIND,exceptregime
Item
If the patient is receiving antiretroviral therapy, has the patient been on a stable regimen for at least 4 weeks prior to study entry? Patients may receive any FDA approved antiretroviral therapy or agents available through a treatment IND, except regime
boolean
Hasthepatienthadaconcurrent,acute,activeopportunisticinfection otherthanoralthrushorgenitalherpeswithin14daysofenrollment?
Item
Has the patient had a concurrent, acute, active opportunistic infection other than oral thrush or genital herpes within 14 days of enrollment?
boolean
DoesthepatienthavevisceralKaposi'sSarcoma?
Item
Does the patient have visceral Kaposi's Sarcoma?
boolean
DoesthepatienthaveoralKaposi'ssarcomaastheonlysiteofdisease?
Item
Does the patient have oral Kaposi's sarcoma as the only site of disease?
boolean
Doesthepatienthaveaconcurrentneoplasmrequiringcytotoxictherapy?
Item
Does the patient have a concurrent neoplasm requiring cytotoxic therapy?
boolean
Hasthepatienthadanti-neoplastictreatmentforKaposi'sSarcoma (includingchemotherapy,radiationtherapy,localtherapy,biological therapy,orinvestigationaltherapy)withintwoweeksofstudyentry?
Item
Has the patient had anti-neoplastic treatment for Kaposi's Sarcoma (including chemotherapy, radiation therapy, local therapy, biological therapy, or investigational therapy) within two weeks of study entry?
boolean
HasthepatienthadpreviouslocaltherapyofanyKS-markerlesion within60days(Exception:thelesionhasclearlyprogressedsince treatment)?
Item
Has the patient had previous local therapy of any KS-marker lesion within 60 days (Exception: the lesion has clearly progressed since treatment)?
boolean
Hasthepatientusedinvestigationalagentsotherthanantiretroviral drugsavailableunderexpandedaccessorcompassionateuseprotocols?
Item
Has the patient used investigational agents other than antiretroviral drugs available under expanded access or compassionate use protocols?
boolean
Doesthepatienthaveahistoryofvalproicacidorvalproateuseinthe previousyear?
Item
Does the patient have a history of valproic acid or valproate use in the previous year?
boolean
DoesthepatienthaveevidenceofapriorMIorcardiacischemia?
Item
Does the patient have evidence of a prior MI or cardiac ischemia?
boolean
IsthepatientusingAZT?
Item
Is the patient using AZT ?
boolean
Doesthepatienthaveahistoryoflacticacidosisgreaterthan 2mmoles/liter?
Item
Does the patient have a history of lactic acidosis greater than 2 mmoles / liter?
boolean
Doesthepatienthaveahistoryoflipoatrophyorhypercholesterolemia secondarytoretroviraltreatment?
Item
Does the patient have a history of lipoatrophy or hypercholesterolemia secondary to retroviral treatment?
boolean
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