ID

3236

Beschrijving

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

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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 NCT00075777 Lab - AMC Clinical Trials - Eligibility Form for Protocol #038 - PR3801 - 2281572v3.0

Engels

No Instruction available.

1 Formulieren  
  1. StudyEvent: AMC Clinical Trials - Eligibility Form for Protocol #038 - PR3801
    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

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

text

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

PatientLifeExpectancyEligibilityDeterminationInd-2

Datatype

text

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

PatientAge18YearsIndicator

Datatype

text

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

text

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

Isthepatient'sbaselineKarnofskyperformancestatus>=60%?

Datatype

text

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

Isthepatient'shemoglobin>=8g/dlwithin14daysofstudyentry?

Datatype

text

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

text

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

text

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

text

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

text

Is the patient's albumin > 2.5?
Beschrijving

Isthepatient'salbumin>2.5?

Datatype

text

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

Doesthepatienthavetheabilityandwillingnesstogiveinformed consent?

Datatype

text

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

text

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

text

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

text

Does the patient have visceral Kaposi's Sarcoma?
Beschrijving

DoesthepatienthavevisceralKaposi'sSarcoma?

Datatype

text

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

DoesthepatienthaveoralKaposi'ssarcomaastheonlysiteofdisease?

Datatype

text

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

Doesthepatienthaveaconcurrentneoplasmrequiringcytotoxictherapy?

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 two weeks of study entry?
Beschrijving

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

Datatype

text

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

text

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

Hasthepatientusedinvestigationalagentsotherthanantiretroviral drugsavailableunderexpandedaccessorcompassionateuseprotocols?

Datatype

text

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

Doesthepatienthaveahistoryofvalproicacidorvalproateuseinthe previousyear?

Datatype

text

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

DoesthepatienthaveevidenceofapriorMIorcardiacischemia?

Datatype

text

Is the patient using AZT ?
Beschrijving

IsthepatientusingAZT?

Datatype

text

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

Doesthepatienthaveahistoryoflacticacidosisgreaterthan 2mmoles/liter?

Datatype

text

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

Doesthepatienthaveahistoryoflipoatrophyorhypercholesterolemia secondarytoretroviraltreatment?

Datatype

text

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Similar models

No Instruction available.

1 Formulieren
  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
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)
Dateofassessment
Item
Date of Assessment
text
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?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12981 (NCI Thesaurus ObjectClass)
C0332835 (UMLS 2011AA ObjectClass)
C14219 (NCI Thesaurus Property)
C0019682 (UMLS 2011AA Property)
C16295 (NCI Thesaurus Property)
C0003241 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.2
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 viral load determination?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
the patient's life expectancy >= 3 months?
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C37987 (NCI Thesaurus Property)
C0376558 (UMLS 2011AA Property)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)
C25359 (NCI Thesaurus Property)
C0679138 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.10
Code List
the patient's life expectancy >= 3 months?
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Is the patient age 18 or older?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.11
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 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?
text
CL.1
Code List
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?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is the patient's baseline Karnofsky performance status >= 60%?
text
CL.3
Code List
Is the patient's baseline Karnofsky performance status >= 60%?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is the patient's hemoglobin >= 8 g/dl within 14 days of study entry?
text
CL.4
Code List
Is the patient's hemoglobin >= 8 g/dl within 14 days of study entry?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is the patient's absolute neutrophil count >= 750 cells/ mm and platelets >=5,000 cells/mm within 14 days of study entry?
text
CL.5
Code List
Is the patient's absolute neutrophil count >= 750 cells/ mm and platelets >=5,000 cells/mm within 14 days of study entry?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is the patient's serum creatinine < 1.5 times the upper limit of normal within 14 days of study entry?
text
CL.6
Code List
Is the patient's serum creatinine < 1.5 times the upper limit of normal within 14 days of study entry?
CL Item
Yes (Yes)
CL Item
No (No)
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?
text
CL.7
Code List
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?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Are the patient's AST (SGOT) and ALT (SGPT) <= 3 x the upper limit of normal within 14 days of study entry ?
text
CL.8
Code List
Are the patient's AST (SGOT) and ALT (SGPT) <= 3 x the upper limit of normal within 14 days of study entry ?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is the patient's albumin > 2.5?
text
CL.9
Code List
Is the patient's albumin > 2.5?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does the patient have the ability and willingness to give informed consent ?
text
CL.12
Code List
Does the patient have the ability and willingness to give informed consent ?
CL Item
Yes (Yes)
CL Item
No (No)
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)
Item
Is the patient capable of complying with the protocol?
text
CL.16
Code List
Is the patient capable of complying with the protocol?
CL Item
Yes (Yes)
CL Item
No (No)
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
text
CL.17
Code List
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
CL Item
Yes (Yes)
CL Item
No (No)
Item
Has the patient had a concurrent, acute, active opportunistic infection other than oral thrush or genital herpes within 14 days of enrollment?
text
CL.18
Code List
Has the patient had a concurrent, acute, active opportunistic infection other than oral thrush or genital herpes within 14 days of enrollment?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does the patient have visceral Kaposi's Sarcoma?
text
CL.19
Code List
Does the patient have visceral Kaposi's Sarcoma?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does the patient have oral Kaposi's sarcoma as the only site of disease?
text
CL.20
Code List
Does the patient have oral Kaposi's sarcoma as the only site of disease?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does the patient have a concurrent neoplasm requiring cytotoxic therapy?
text
CL.21
Code List
Does the patient have a concurrent neoplasm requiring cytotoxic therapy?
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 two weeks of study entry?
text
CL.22
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 two weeks of study entry?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Has the patient had previous local therapy of any KS-marker lesion within 60 days (Exception: the lesion has clearly progressed since treatment)?
text
CL.23
Code List
Has the patient had previous local therapy of any KS-marker lesion within 60 days (Exception: the lesion has clearly progressed since treatment)?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Has the patient used investigational agents other than antiretroviral drugs available under expanded access or compassionate use protocols?
text
CL.24
Code List
Has the patient used investigational agents other than antiretroviral drugs available under expanded access or compassionate use protocols?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does the patient have a history of valproic acid or valproate use in the previous year?
text
CL.25
Code List
Does the patient have a history of valproic acid or valproate use in the previous year?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does the patient have evidence of a prior MI or cardiac ischemia?
text
CL.26
Code List
Does the patient have evidence of a prior MI or cardiac ischemia?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Is the patient using AZT ?
text
CL.27
Code List
Is the patient using AZT ?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does the patient have a history of lactic acidosis greater than 2 mmoles / liter?
text
CL.28
Code List
Does the patient have a history of lactic acidosis greater than 2 mmoles / liter?
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does the patient have a history of lipoatrophy or hypercholesterolemia secondary to retroviral treatment?
text
CL.29
Code List
Does the patient have a history of lipoatrophy or hypercholesterolemia secondary to retroviral treatment?
CL Item
Yes (Yes)
CL Item
No (No)
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