ID

11262

Beschrijving

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

Trefwoorden

  1. 19-09-12 19-09-12 -
  2. 09-01-15 09-01-15 - Martin Dugas
  3. 27-06-15 27-06-15 -
Geüploaded op

27 juni 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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AMC Clinical Trials - Eligibility Form for Protocol #038 - PR3801 NCT00075777

No Instruction available.

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

Eligibility Assessment

Patient Initials
Beschrijving

Patient Initials

Datatype

text

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

Patient Study ID

Datatype

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
Beschrijving

Dateofassessment

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 viral load determination?
Beschrijving

TransplantPatientHumanImmunodeficiencyVirusAntibodyInd-3

Datatype

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?
Beschrijving

PatientLifeExpectancyEligibilityDeterminationInd-2

Datatype

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?
Beschrijving

PatientAge18YearsIndicator

Datatype

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?
Beschrijving

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

Datatype

boolean

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

Isthepatient'sbaselineKarnofskyperformancestatus>=60%?

Datatype

boolean

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

Isthepatient'shemoglobin>=8g/dlwithin14daysofstudyentry?

Datatype

boolean

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

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

Datatype

boolean

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

Isthepatient'sserumcreatinine<1.5timestheupperlimitofnormalwithin14daysofstudyentry?

Datatype

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?
Beschrijving

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

Datatype

boolean

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

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

Datatype

boolean

Is the patient's albumin > 2.5?
Beschrijving

Isthepatient'salbumin>2.5?

Datatype

boolean

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

Doesthepatienthavetheabilityandwillingnesstogiveinformed consent?

Datatype

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?
Beschrijving

Ifthepatientisafemalecapableofchildbearing,hasshehada negativeserumbeta-HCGwithin72hourspriortostudyentry?

Datatype

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?
Beschrijving

Ifthepatientisafemalecapableofchildbearing,doessheagree topracticeadequatebirthcontroltopreventpregnancywhile receivingtreatmentandforthreemonthsaftertreatmentis discontinued?

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

Is the patient capable of complying with the protocol?
Beschrijving

Isthepatientcapableofcomplyingwiththeprotocol?

Datatype

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
Beschrijving

Ifthepatientisreceivingantiretroviraltherapy,hasthepatientbeenonastableregimenforatleast4weekspriortostudyentry?PatientsmayreceiveanyFDAapprovedantiretroviraltherapyoragentsavailablethroughatreatmentIND,exceptregime

Datatype

boolean

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

Hasthepatienthadaconcurrent,acute,activeopportunisticinfection otherthanoralthrushorgenitalherpeswithin14daysofenrollment?

Datatype

boolean

Does the patient have visceral Kaposi's Sarcoma?
Beschrijving

DoesthepatienthavevisceralKaposi'sSarcoma?

Datatype

boolean

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

DoesthepatienthaveoralKaposi'ssarcomaastheonlysiteofdisease?

Datatype

boolean

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

Doesthepatienthaveaconcurrentneoplasmrequiringcytotoxictherapy?

Datatype

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?
Beschrijving

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

Datatype

boolean

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

HasthepatienthadpreviouslocaltherapyofanyKS-markerlesion within60days(Exception:thelesionhasclearlyprogressedsince treatment)?

Datatype

boolean

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

Hasthepatientusedinvestigationalagentsotherthanantiretroviral drugsavailableunderexpandedaccessorcompassionateuseprotocols?

Datatype

boolean

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

Doesthepatienthaveahistoryofvalproicacidorvalproateuseinthe previousyear?

Datatype

boolean

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

DoesthepatienthaveevidenceofapriorMIorcardiacischemia?

Datatype

boolean

Is the patient using AZT ?
Beschrijving

IsthepatientusingAZT?

Datatype

boolean

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

Doesthepatienthaveahistoryoflacticacidosisgreaterthan 2mmoles/liter?

Datatype

boolean

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

Doesthepatienthaveahistoryoflipoatrophyorhypercholesterolemia secondarytoretroviraltreatment?

Datatype

boolean

Similar models

No Instruction available.

  1. StudyEvent: AMC Clinical Trials - Eligibility Form for Protocol #038 - PR3801
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
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
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
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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