ID

3236

Beschreibung

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

Stichworte

Versionen (3)
  1. 19.09.12 19.09.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
  3. 27.06.15 27.06.15 -
Hochgeladen am

19. September 2012

DOI

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

Englisch

No Instruction available.

1 Formulare  
  1. StudyEvent: AMC Clinical Trials - Eligibility Form for Protocol #038 - PR3801
    1. No Instruction available.
Unnamed 1
Beschreibung

Unnamed 1

Patient Initials
Beschreibung

PatientInitialsName

Datentyp

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
Beschreibung

PatientCoordinatingIdentifierNumber

Datentyp

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
Beschreibung

Dateofassessment

Datentyp

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?
Beschreibung

TransplantPatientHumanImmunodeficiencyVirusAntibodyInd-3

Datentyp

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?
Beschreibung

PatientLifeExpectancyEligibilityDeterminationInd-2

Datentyp

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?
Beschreibung

PatientAge18YearsIndicator

Datentyp

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?
Beschreibung

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

Datentyp

text

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

Isthepatient'sbaselineKarnofskyperformancestatus>=60%?

Datentyp

text

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

Isthepatient'shemoglobin>=8g/dlwithin14daysofstudyentry?

Datentyp

text

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

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

Datentyp

text

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

Isthepatient'sserumcreatinine<1.5timestheupperlimitofnormalwithin14daysofstudyentry?

Datentyp

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?
Beschreibung

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

Datentyp

text

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

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

Datentyp

text

Is the patient's albumin > 2.5?
Beschreibung

Isthepatient'salbumin>2.5?

Datentyp

text

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

Doesthepatienthavetheabilityandwillingnesstogiveinformed consent?

Datentyp

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?
Beschreibung

Ifthepatientisafemalecapableofchildbearing,hasshehada negativeserumbeta-HCGwithin72hourspriortostudyentry?

Datentyp

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?
Beschreibung

Ifthepatientisafemalecapableofchildbearing,doessheagree topracticeadequatebirthcontroltopreventpregnancywhile receivingtreatmentandforthreemonthsaftertreatmentis discontinued?

Datentyp

text

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

Ifthepatientisamaleofchildfatheringpotential,doesheagreetopracticeadequatebirthcontrol?

Datentyp

text

Is the patient capable of complying with the protocol?
Beschreibung

Isthepatientcapableofcomplyingwiththeprotocol?

Datentyp

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
Beschreibung

Ifthepatientisreceivingantiretroviraltherapy,hasthepatientbeenonastableregimenforatleast4weekspriortostudyentry?PatientsmayreceiveanyFDAapprovedantiretroviraltherapyoragentsavailablethroughatreatmentIND,exceptregime

Datentyp

text

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

Hasthepatienthadaconcurrent,acute,activeopportunisticinfection otherthanoralthrushorgenitalherpeswithin14daysofenrollment?

Datentyp

text

Does the patient have visceral Kaposi's Sarcoma?
Beschreibung

DoesthepatienthavevisceralKaposi'sSarcoma?

Datentyp

text

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

DoesthepatienthaveoralKaposi'ssarcomaastheonlysiteofdisease?

Datentyp

text

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

Doesthepatienthaveaconcurrentneoplasmrequiringcytotoxictherapy?

Datentyp

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?
Beschreibung

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

Datentyp

text

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

HasthepatienthadpreviouslocaltherapyofanyKS-markerlesion within60days(Exception:thelesionhasclearlyprogressedsince treatment)?

Datentyp

text

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

Hasthepatientusedinvestigationalagentsotherthanantiretroviral drugsavailableunderexpandedaccessorcompassionateuseprotocols?

Datentyp

text

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

Doesthepatienthaveahistoryofvalproicacidorvalproateuseinthe previousyear?

Datentyp

text

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

DoesthepatienthaveevidenceofapriorMIorcardiacischemia?

Datentyp

text

Is the patient using AZT ?
Beschreibung

IsthepatientusingAZT?

Datentyp

text

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

Doesthepatienthaveahistoryoflacticacidosisgreaterthan 2mmoles/liter?

Datentyp

text

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

Doesthepatienthaveahistoryoflipoatrophyorhypercholesterolemia secondarytoretroviraltreatment?

Datentyp

text

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Ähnliche Modelle

No Instruction available.

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