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4503

Beschreibung

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

Link

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

Stichworte

Versionen (2)
  1. 09.12.13 09.12.13 - Martin Dugas
  2. 02.06.15 02.06.15 -
Hochgeladen am

9. Dezember 2013

DOI

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    ACNS1123 Eligibility - 3377519v1.0

    Englisch

    No Instruction available.

    1 Formulare  
    1. StudyEvent: SE.0000
      1. No Instruction available.
    Stratification
    Beschreibung

    Stratification

    ACNS1123 Stratum
    Beschreibung

    ClinicalStudyACNS1123StratificationFactorsType

    Datentyp

    text

    Study Treatment
    Beschreibung

    TreatmentAssignmentType

    Datentyp

    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.)
    Beschreibung

    TreatmentBeginDate

    Datentyp

    date

    Elig - Block 1
    Beschreibung

    Elig - Block 1

    Is the patient enrolled on the ALTE07C1 study?
    Beschreibung

    OtherStudyEnrollmentInd-2

    Datentyp

    text

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

    PatientAgeEligibilityDeterminationInd-2

    Datentyp

    text

    Was definitive diagnostic surgery performed?
    Beschreibung

    FirstDiagnosisFromSurgicalProcedureIndicator

    Datentyp

    text

    Date of definitive diagnostic surgery or clinical diagnosis:
    Beschreibung

    PersonSuspectedClinicalDiagnosisEligibilityCriteriaDate

    Datentyp

    date

    Was lumbar CSF cytology obtained?
    Beschreibung

    CerebrospinalFluidCellInd-3

    Datentyp

    text

    Was it medically contraindicated? (If no,)
    Beschreibung

    CerebrospinalFluidDiagnosticProcedureCytologyContraindicatedInd-2

    Datentyp

    text

    Was lumbar CSF cytology negative?
    Beschreibung

    LaboratoryProcedureLumbarPunctureCerebrospinalFluidNegativeFindingOutcomeInd-2

    Datentyp

    text

    Elig - Block 2
    Beschreibung

    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)
    Beschreibung

    GermCellTumorHistologicClassificationDiagnosisInd-2

    Datentyp

    text

    Elig - Block 3
    Beschreibung

    Elig - Block 3

    Does patient have newly diagnosed localized primary CNS NGGCT?
    Beschreibung

    NewPrimaryMalignantNeoplasmCentralNervousSystemGermCellTumorDiagnosisInd-2

    Datentyp

    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)
    Beschreibung

    PathologyFindingsIndicator

    Datentyp

    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.)
    Beschreibung

    PatientProtocolRequirementEligibilityDeterminationInd-2

    Datentyp

    text

    Elig - Block 4
    Beschreibung

    Elig - Block 4

    Does patient have newly diagnosed localized primary CNS germinoma?
    Beschreibung

    NewChildhoodBrainGerminomaDiagnosisInd-2

    Datentyp

    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.)
    Beschreibung

    PatientProtocolRequirementEligibilityDeterminationInd-2

    Datentyp

    text

    Elig - Block 5
    Beschreibung

    Elig - Block 5

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

    LaboratoryProcedureAbsoluteNeutrophilCountResultSpecifiedValue

    Datentyp

    double

    Maßeinheiten
    • ul
    ul
    Platelet count (number/uL): (Transfusion Independent)
    Beschreibung

    LaboratoryProcedurePlateletResultSpecifiedValue

    Datentyp

    double

    Maßeinheiten
    • 1000/uL
    1000/uL
    Hemoglobin(g/dL) (May receive RBC transfusion)
    Beschreibung

    LaboratoryProcedureHemoglobinResultSpecifiedValue

    Datentyp

    double

    Maßeinheiten
    • g/dL
    g/dL
    Elig - Block 5
    Beschreibung

    Elig - Block 5

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

    LaboratoryProcedureCreatinineClearanceOutcomeValue

    Datentyp

    double

    Radioisotope GFR(mL/min/1.73 m²)
    Beschreibung

    LaboratoryProcedureGlomerularFiltrationRateOutcomeSpecifiedValue

    Datentyp

    double

    Maßeinheiten
    • 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)
    Beschreibung

    LaboratoryProcedureCreatinineResultSpecifiedValue

    Datentyp

    double

    Maßeinheiten
    • mg/dL
    mg/dL
    Elig - Block 7
    Beschreibung

    Elig - Block 7

    Total bilirubin (mg/dl), ULN
    Beschreibung

    LaboratoryProcedureTotalBilirubinResultSpecifiedUpperLimitofNormalValue

    Datentyp

    double

    Maßeinheiten
    • mg/dL
    mg/dL
    Total bilirubin Value (mg/dl):
    Beschreibung

    LaboratoryProcedureTotalBilirubinResultValue

    Datentyp

    double

    Maßeinheiten
    • mg/dL
    mg/dL
    SGPT (ALT) or SGOT (AST) U/L, ULN:
    Beschreibung

    LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

    Datentyp

    double

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

    LaboratoryProcedureAlanineAminotransferaseMeasurementAspartateAminotransferaseMeasurementOutcomeValue

    Datentyp

    double

    Elig - Block 8
    Beschreibung

    Elig - Block 8

    Does patient have seizure disorder?
    Beschreibung

    PatientSeizureDiseaseorDisorderInd-3

    Datentyp

    text

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

    NeurologicalEvaluationSeizureSymptomInd-2

    Datentyp

    text

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

    PatientMechanicalVentilationUseInd-2

    Datentyp

    text

    Elig - Block 9
    Beschreibung

    Elig - Block 9

    Does patient have mature teratoma with normal tumor markers?
    Beschreibung

    PatientCentralNervousSystemGermCellTumorDiagnosisInd-2

    Datentyp

    text

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

    ExternalBrainVentricleCentralNervousSystemGermCellTumorDiagnosisInd-2

    Datentyp

    text

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

    MetastaticDiseaseorDisorderMagneticResonanceImagingCerebrospinalFluidDiagnosisInd-2

    Datentyp

    text

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

    SurgicalInterventionCorticosteroidAdministeredInd-2

    Datentyp

    text

    Is patient post menarcheal?
    Beschreibung

    PediatricEndocrineMensesOnsetInd-2

    Datentyp

    text

    Was a pregnancy test performed?
    Beschreibung

    PatientPregnancyTestIndicator

    Datentyp

    text

    Is patient pregnant? (If yes above,)
    Beschreibung

    PatientPregnancyInd-2

    Datentyp

    text

    Is patient nursing?
    Beschreibung

    PersonBreastFeedingExclusionCriteriaIndicator

    Datentyp

    text

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

    BreastFeedingStopAgreementInd-4

    Datentyp

    text

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

    ContraceptionAgreementInd

    Datentyp

    text

    Elig - Block 10
    Beschreibung

    Elig - Block 10

    Date Informed Consent Signed
    Beschreibung

    InformedConsentFormSignedDate

    Datentyp

    date

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

    StudyCompleteRequirementsInd-2

    Datentyp

    text

    Comments
    Beschreibung

    ResearchCommentsText

    Datentyp

    text

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    Ähnliche Modelle

    No Instruction available.

    1 Formulare
    1. StudyEvent: SE.0000
      1. No Instruction available.
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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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