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ID

4503

Descrizione

ACNS1123 Eligibility Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=

Keywords

versioni (2)
  1. 09.12.13 09.12.13 - Martin Dugas
  2. 02.06.15 02.06.15 -
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9. Dezember 2013

DOI

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    ACNS1123 Eligibility - 3377519v1.0

    Inglese

    No Instruction available.

    1 moduli  
    1. StudyEvent: SE.0000
      1. No Instruction available.
    Stratification
    Descrizione

    Stratification

    ACNS1123 Stratum
    Descrizione

    ClinicalStudyACNS1123StratificationFactorsType

    Tipo di dati

    text

    Study Treatment
    Descrizione

    TreatmentAssignmentType

    Tipo di dati

    text

    Treatment Begin Date (Projected date must be no later than 5 calendar days after the date of study enrollment. Enter as MM/DD/YYYY.)
    Descrizione

    TreatmentBeginDate

    Tipo di dati

    date

    Elig - Block 1
    Descrizione

    Elig - Block 1

    Is the patient enrolled on the ALTE07C1 study?
    Descrizione

    OtherStudyEnrollmentInd-2

    Tipo di dati

    text

    Is the patient greater than or equal to 3 years and less than or equal to 21 years at the time of enrollment?
    Descrizione

    PatientAgeEligibilityDeterminationInd-2

    Tipo di dati

    text

    Was definitive diagnostic surgery performed?
    Descrizione

    FirstDiagnosisFromSurgicalProcedureIndicator

    Tipo di dati

    text

    Date of definitive diagnostic surgery or clinical diagnosis:
    Descrizione

    PersonSuspectedClinicalDiagnosisEligibilityCriteriaDate

    Tipo di dati

    date

    Was lumbar CSF cytology obtained?
    Descrizione

    CerebrospinalFluidCellInd-3

    Tipo di dati

    text

    Was it medically contraindicated? (If no,)
    Descrizione

    CerebrospinalFluidDiagnosticProcedureCytologyContraindicatedInd-2

    Tipo di dati

    text

    Was lumbar CSF cytology negative?
    Descrizione

    LaboratoryProcedureLumbarPunctureCerebrospinalFluidNegativeFindingOutcomeInd-2

    Tipo di dati

    text

    Elig - Block 2
    Descrizione

    Elig - Block 2

    Does patient have germ cell tumor(s) located in the suprasellar, pineal, bifocal (pineal + suprasellar) or ventricles? (Tumors present in the above mentioned locations and with unifocal parenchymal extension)
    Descrizione

    GermCellTumorHistologicClassificationDiagnosisInd-2

    Tipo di dati

    text

    Elig - Block 3
    Descrizione

    Elig - Block 3

    Does patient have newly diagnosed localized primary CNS NGGCT?
    Descrizione

    NewPrimaryMalignantNeoplasmCentralNervousSystemGermCellTumorDiagnosisInd-2

    Tipo di dati

    text

    Does patient have any of the following elements on biopsy/resection? (endodermal sinus tumor yolk sacor embryonal carcinoma or choriocarcinoma or malignant/immature teratoma or mixed GCT with malignant GCT elements)
    Descrizione

    PathologyFindingsIndicator

    Tipo di dati

    text

    Does patient meet any of the following criteria: (Institutional normal AFP and hCGB 5mIU/mL - <= 50mIU/mL in serum and/or CSF or Bifocal pineal + suprasellar involvement or pineal lesion with diabetes insipidus DI AND hCGB<=100mIU/mL and institutional normal AFP in serum/or CSF or Histologically confirmed germinoma mixed with mature teratoma and hCGB <= 100mIU/mL and institutional normal AFP in serum/or CSF.)
    Descrizione

    PatientProtocolRequirementEligibilityDeterminationInd-2

    Tipo di dati

    text

    Elig - Block 4
    Descrizione

    Elig - Block 4

    Does patient have newly diagnosed localized primary CNS germinoma?
    Descrizione

    NewChildhoodBrainGerminomaDiagnosisInd-2

    Tipo di dati

    text

    Does patient meet any of the following criteria: (Institutional normal AFP and hCGB 5mIU/mL - <= 50mIU/mL in serum and/or CSF or Bifocal pineal + suprasellar involvement or pineal lesion with diabetes insipidus DI AND hCGB<=100mIU/mL and institutional normal AFP in serum/or CSF or Histologically confirmed germinoma mixed with mature teratoma and hCGB <= 100mIU/mL and institutional normal AFP in serum/or CSF.)
    Descrizione

    PatientProtocolRequirementEligibilityDeterminationInd-2

    Tipo di dati

    text

    Elig - Block 5
    Descrizione

    Elig - Block 5

    Peripheral absolute neutrophil count (ANC) (number/uL)
    Descrizione

    LaboratoryProcedureAbsoluteNeutrophilCountResultSpecifiedValue

    Tipo di dati

    double

    Unità di misura
    • ul
    ul
    Platelet count (number/uL): (Transfusion Independent)
    Descrizione

    LaboratoryProcedurePlateletResultSpecifiedValue

    Tipo di dati

    double

    Unità di misura
    • 1000/uL
    1000/uL
    Hemoglobin(g/dL) (May receive RBC transfusion)
    Descrizione

    LaboratoryProcedureHemoglobinResultSpecifiedValue

    Tipo di dati

    double

    Unità di misura
    • g/dL
    g/dL
    Elig - Block 5
    Descrizione

    Elig - Block 5

    Creatinine clearance (mL/min/1.73m²):
    Descrizione

    LaboratoryProcedureCreatinineClearanceOutcomeValue

    Tipo di dati

    double

    Radioisotope GFR(mL/min/1.73 m²)
    Descrizione

    LaboratoryProcedureGlomerularFiltrationRateOutcomeSpecifiedValue

    Tipo di dati

    double

    Unità di misura
    • mL/Min/1.73m2
    mL/Min/1.73m2
    Serum creatinine (mg/dL) (At study entry and based on age/gender per protocol section 3.2.5.2)
    Descrizione

    LaboratoryProcedureCreatinineResultSpecifiedValue

    Tipo di dati

    double

    Unità di misura
    • mg/dL
    mg/dL
    Elig - Block 7
    Descrizione

    Elig - Block 7

    Total bilirubin (mg/dl), ULN
    Descrizione

    LaboratoryProcedureTotalBilirubinResultSpecifiedUpperLimitofNormalValue

    Tipo di dati

    double

    Unità di misura
    • mg/dL
    mg/dL
    Total bilirubin Value (mg/dl):
    Descrizione

    LaboratoryProcedureTotalBilirubinResultValue

    Tipo di dati

    double

    Unità di misura
    • mg/dL
    mg/dL
    SGPT (ALT) or SGOT (AST) U/L, ULN:
    Descrizione

    LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

    Tipo di dati

    double

    SGPT (ALT) or SGOT (AST), U/L
    Descrizione

    LaboratoryProcedureAlanineAminotransferaseMeasurementAspartateAminotransferaseMeasurementOutcomeValue

    Tipo di dati

    double

    Elig - Block 8
    Descrizione

    Elig - Block 8

    Does patient have seizure disorder?
    Descrizione

    PatientSeizureDiseaseorDisorderInd-3

    Tipo di dati

    text

    Is patient's seizure disorder well controlled? (Adequate central nervous system function as defined in protocol section 3.2.5.4)
    Descrizione

    NeurologicalEvaluationSeizureSymptomInd-2

    Tipo di dati

    text

    Is patient in status, coma or assisted ventilation at study entry?
    Descrizione

    PatientMechanicalVentilationUseInd-2

    Tipo di dati

    text

    Elig - Block 9
    Descrizione

    Elig - Block 9

    Does patient have mature teratoma with normal tumor markers?
    Descrizione

    PatientCentralNervousSystemGermCellTumorDiagnosisInd-2

    Tipo di dati

    text

    Does patient have tumors located outside the ventricles? (basal ganglia, thalamus)
    Descrizione

    ExternalBrainVentricleCentralNervousSystemGermCellTumorDiagnosisInd-2

    Tipo di dati

    text

    Does patient have metastatic disease by either MRI evaluation or lumbar CSF cytology?
    Descrizione

    MetastaticDiseaseorDisorderMagneticResonanceImagingCerebrospinalFluidDiagnosisInd-2

    Tipo di dati

    text

    Prior to study enrollment, has patient been treated with therapy other than surgical intervention and corticosteroids?
    Descrizione

    SurgicalInterventionCorticosteroidAdministeredInd-2

    Tipo di dati

    text

    Is patient post menarcheal?
    Descrizione

    PediatricEndocrineMensesOnsetInd-2

    Tipo di dati

    text

    Was a pregnancy test performed?
    Descrizione

    PatientPregnancyTestIndicator

    Tipo di dati

    text

    Is patient pregnant? (If yes above,)
    Descrizione

    PatientPregnancyInd-2

    Tipo di dati

    text

    Is patient nursing?
    Descrizione

    PersonBreastFeedingExclusionCriteriaIndicator

    Tipo di dati

    text

    Has patient agreed to stop breastfeeding? (If yes above,)
    Descrizione

    BreastFeedingStopAgreementInd-4

    Tipo di dati

    text

    Has patient agreed to use an effective contraceptive method for the duration of the study participation?
    Descrizione

    ContraceptionAgreementInd

    Tipo di dati

    text

    Elig - Block 10
    Descrizione

    Elig - Block 10

    Date Informed Consent Signed
    Descrizione

    InformedConsentFormSignedDate

    Tipo di dati

    date

    Have all institutional, FDA, and NCI requirements for human studies been met?
    Descrizione

    StudyCompleteRequirementsInd-2

    Tipo di dati

    text

    Comments
    Descrizione

    ResearchCommentsText

    Tipo di dati

    text

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    Similar models

    No Instruction available.

    1 moduli
    1. StudyEvent: SE.0000
      1. No Instruction available.
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Stratification
    CL.1
    Code List
    ACNS1123 Stratum
    CL Item
    Stratum 1 - Nggct (Stratum 1 - NGGCT)
    CL Item
    Stratum 2 - Germinoma (Stratum 2 - Germinoma)
    Item
    Study Treatment
    text
    CL.2
    Code List
    Study Treatment
    CL Item
    Treatment 1: A,b,a,b,a,b (Treatment 1 A B A B A B)
    CL Item
    Treatment 2: A,a,a,a (Treatment 2 A A A A)
    TreatmentBeginDate
    Item
    Treatment Begin Date (Projected date must be no later than 5 calendar days after the date of study enrollment. Enter as MM/DD/YYYY.)
    date
    Item Group
    Elig - Block 1
    Item
    Is the patient enrolled on the ALTE07C1 study?
    text
    CL.3
    Code List
    Is the patient enrolled on the ALTE07C1 study?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item
    Is the patient greater than or equal to 3 years and less than or equal to 21 years at the time of enrollment?
    text
    CL.4
    Code List
    Is the patient greater than or equal to 3 years and less than or equal to 21 years at the time of enrollment?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item
    Was definitive diagnostic surgery performed?
    text
    CL.5
    Code List
    Was definitive diagnostic surgery performed?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    PersonSuspectedClinicalDiagnosisEligibilityCriteriaDate
    Item
    Date of definitive diagnostic surgery or clinical diagnosis:
    date
    Item
    Was lumbar CSF cytology obtained?
    text
    CL.6
    Code List
    Was lumbar CSF cytology obtained?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item
    Was it medically contraindicated? (If no,)
    text
    CL.7
    Code List
    Was it medically contraindicated? (If no,)
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL.8
    Code List
    Was lumbar CSF cytology negative?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item Group
    Elig - Block 2
    Item
    Does patient have germ cell tumor(s) located in the suprasellar, pineal, bifocal (pineal + suprasellar) or ventricles? (Tumors present in the above mentioned locations and with unifocal parenchymal extension)
    text
    CL.9
    Code List
    Does patient have germ cell tumor(s) located in the suprasellar, pineal, bifocal (pineal + suprasellar) or ventricles? (Tumors present in the above mentioned locations and with unifocal parenchymal extension)
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item Group
    Elig - Block 3
    Item
    Does patient have newly diagnosed localized primary CNS NGGCT?
    text
    CL.10
    Code List
    Does patient have newly diagnosed localized primary CNS NGGCT?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item
    Does patient have any of the following elements on biopsy/resection? (endodermal sinus tumor yolk sacor embryonal carcinoma or choriocarcinoma or malignant/immature teratoma or mixed GCT with malignant GCT elements)
    text
    CL.11
    Code List
    Does patient have any of the following elements on biopsy/resection? (endodermal sinus tumor yolk sacor embryonal carcinoma or choriocarcinoma or malignant/immature teratoma or mixed GCT with malignant GCT elements)
    CL Item
    Yes (YES)
    CL Item
    No (NO)
    Item
    Does patient meet any of the following criteria: (Institutional normal AFP and hCGB 5mIU/mL - <= 50mIU/mL in serum and/or CSF or Bifocal pineal + suprasellar involvement or pineal lesion with diabetes insipidus DI AND hCGB<=100mIU/mL and institutional normal AFP in serum/or CSF or Histologically confirmed germinoma mixed with mature teratoma and hCGB <= 100mIU/mL and institutional normal AFP in serum/or CSF.)
    text
    CL.14
    Code List
    Does patient meet any of the following criteria: (Institutional normal AFP and hCGB 5mIU/mL - <= 50mIU/mL in serum and/or CSF or Bifocal pineal + suprasellar involvement or pineal lesion with diabetes insipidus DI AND hCGB<=100mIU/mL and institutional normal AFP in serum/or CSF or Histologically confirmed germinoma mixed with mature teratoma and hCGB <= 100mIU/mL and institutional normal AFP in serum/or CSF.)
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item
    Does patient have newly diagnosed localized primary CNS germinoma?
    text
    CL.13
    Code List
    Does patient have newly diagnosed localized primary CNS germinoma?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item
    Does patient meet any of the following criteria: (Institutional normal AFP and hCGB 5mIU/mL - <= 50mIU/mL in serum and/or CSF or Bifocal pineal + suprasellar involvement or pineal lesion with diabetes insipidus DI AND hCGB<=100mIU/mL and institutional normal AFP in serum/or CSF or Histologically confirmed germinoma mixed with mature teratoma and hCGB <= 100mIU/mL and institutional normal AFP in serum/or CSF.)
    text
    CL.14
    Code List
    Does patient meet any of the following criteria: (Institutional normal AFP and hCGB 5mIU/mL - <= 50mIU/mL in serum and/or CSF or Bifocal pineal + suprasellar involvement or pineal lesion with diabetes insipidus DI AND hCGB<=100mIU/mL and institutional normal AFP in serum/or CSF or Histologically confirmed germinoma mixed with mature teratoma and hCGB <= 100mIU/mL and institutional normal AFP in serum/or CSF.)
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    LaboratoryProcedureAbsoluteNeutrophilCountResultSpecifiedValue
    Item
    Peripheral absolute neutrophil count (ANC) (number/uL)
    double
    LaboratoryProcedurePlateletResultSpecifiedValue
    Item
    Platelet count (number/uL): (Transfusion Independent)
    double
    LaboratoryProcedureHemoglobinResultSpecifiedValue
    Item
    Hemoglobin(g/dL) (May receive RBC transfusion)
    double
    LaboratoryProcedureCreatinineClearanceOutcomeValue
    Item
    Creatinine clearance (mL/min/1.73m²):
    double
    LaboratoryProcedureGlomerularFiltrationRateOutcomeSpecifiedValue
    Item
    Radioisotope GFR(mL/min/1.73 m²)
    double
    LaboratoryProcedureCreatinineResultSpecifiedValue
    Item
    Serum creatinine (mg/dL) (At study entry and based on age/gender per protocol section 3.2.5.2)
    double
    LaboratoryProcedureTotalBilirubinResultSpecifiedUpperLimitofNormalValue
    Item
    Total bilirubin (mg/dl), ULN
    double
    LaboratoryProcedureTotalBilirubinResultValue
    Item
    Total bilirubin Value (mg/dl):
    double
    LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue
    Item
    SGPT (ALT) or SGOT (AST) U/L, ULN:
    double
    LaboratoryProcedureAlanineAminotransferaseMeasurementAspartateAminotransferaseMeasurementOutcomeValue
    Item
    SGPT (ALT) or SGOT (AST), U/L
    double
    Item Group
    Elig - Block 8
    Item
    Does patient have seizure disorder?
    text
    CL.15
    Code List
    Does patient have seizure disorder?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item
    Is patient's seizure disorder well controlled? (Adequate central nervous system function as defined in protocol section 3.2.5.4)
    text
    CL.16
    Code List
    Is patient's seizure disorder well controlled? (Adequate central nervous system function as defined in protocol section 3.2.5.4)
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item
    Is patient in status, coma or assisted ventilation at study entry?
    text
    CL.17
    Code List
    Is patient in status, coma or assisted ventilation at study entry?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item Group
    Elig - Block 9
    Item
    Does patient have mature teratoma with normal tumor markers?
    text
    CL.18
    Code List
    Does patient have mature teratoma with normal tumor markers?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item
    Does patient have tumors located outside the ventricles? (basal ganglia, thalamus)
    text
    CL.19
    Code List
    Does patient have tumors located outside the ventricles? (basal ganglia, thalamus)
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item
    Does patient have metastatic disease by either MRI evaluation or lumbar CSF cytology?
    text
    CL.20
    Code List
    Does patient have metastatic disease by either MRI evaluation or lumbar CSF cytology?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item
    Prior to study enrollment, has patient been treated with therapy other than surgical intervention and corticosteroids?
    text
    CL.21
    Code List
    Prior to study enrollment, has patient been treated with therapy other than surgical intervention and corticosteroids?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item
    Is patient post menarcheal?
    text
    CL.22
    Code List
    Is patient post menarcheal?
    CL Item
    Yes (yes)
    CL Item
    No (no)
    Item
    Was a pregnancy test performed?
    text
    CL.23
    Code List
    Was a pregnancy test performed?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item
    Is patient pregnant? (If yes above,)
    text
    CL.24
    Code List
    Is patient pregnant? (If yes above,)
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL.25
    Code List
    Is patient nursing?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item
    Has patient agreed to stop breastfeeding? (If yes above,)
    text
    CL.26
    Code List
    Has patient agreed to stop breastfeeding? (If yes above,)
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Item
    Has patient agreed to use an effective contraceptive method for the duration of the study participation?
    text
    CL.27
    Code List
    Has patient agreed to use an effective contraceptive method for the duration of the study participation?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    N/a, Patient Is Not Of Reproductive Potential (NA patient is not of reproductive potential)
    Item Group
    Elig - Block 10
    InformedConsentFormSignedDate
    Item
    Date Informed Consent Signed
    date
    Item
    Have all institutional, FDA, and NCI requirements for human studies been met?
    text
    CL.28
    Code List
    Have all institutional, FDA, and NCI requirements for human studies been met?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    ResearchCommentsText
    Item
    Comments
    text
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