ID

10452

Beskrivning

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

Länk

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

Nyckelord

Versioner (2)
  1. 2013-12-09 2013-12-09 - Martin Dugas
  2. 2015-06-02 2015-06-02 -
Uppladdad den

2 juni 2015

DOI

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Creative Commons BY-NC 3.0 Legacy
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ACNS1123 Eligibility

Engelsk

No Instruction available.

1 Formulär  
  1. StudyEvent: SE.0000
    1. No Instruction available.
Stratification
Beskrivning

Stratification

ACNS1123 Stratum
Beskrivning

ClinicalStudyACNS1123StratificationFactorsType

Datatyp

text

Study Treatment
Beskrivning

TreatmentAssignmentType

Datatyp

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.)
Beskrivning

TreatmentBeginDate

Datatyp

date

TUMOR LOCATION Elig - Block 1
Beskrivning

TUMOR LOCATION Elig - Block 1

Is the patient enrolled on the ALTE07C1 study?
Beskrivning

OtherStudyEnrollmentInd-2

Datatyp

text

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

PatientAgeEligibilityDeterminationInd-2

Datatyp

text

Was definitive diagnostic surgery performed?
Beskrivning

FirstDiagnosisFromSurgicalProcedureIndicator

Datatyp

text

Date of definitive diagnostic surgery or clinical diagnosis:
Beskrivning

PersonSuspectedClinicalDiagnosisEligibilityCriteriaDate

Datatyp

date

Was lumbar CSF cytology obtained?
Beskrivning

CerebrospinalFluidCellInd-3

Datatyp

text

Was it medically contraindicated? (If no,)
Beskrivning

CerebrospinalFluidDiagnosticProcedureCytologyContraindicatedInd-2

Datatyp

text

Was lumbar CSF cytology negative?
Beskrivning

LaboratoryProcedureLumbarPunctureCerebrospinalFluidNegativeFindingOutcomeInd-2

Datatyp

text

TUMOR LOCATION Elig - Block 2
Beskrivning

TUMOR LOCATION 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)
Beskrivning

GermCellTumorHistologicClassificationDiagnosisInd-2

Datatyp

text

Elig - Block 3
Beskrivning

Elig - Block 3

Does patient have newly diagnosed localized primary CNS NGGCT?
Beskrivning

NewPrimaryMalignantNeoplasmCentralNervousSystemGermCellTumorDiagnosisInd-2

Datatyp

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)
Beskrivning

PathologyFindingsIndicator

Datatyp

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.)
Beskrivning

PatientProtocolRequirementEligibilityDeterminationInd-2

Datatyp

text

Elig - Block 4
Beskrivning

Elig - Block 4

Does patient have newly diagnosed localized primary CNS germinoma?
Beskrivning

NewChildhoodBrainGerminomaDiagnosisInd-2

Datatyp

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.)
Beskrivning

PatientProtocolRequirementEligibilityDeterminationInd-2

Datatyp

text

Elig - Block 5
Beskrivning

Elig - Block 5

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

LaboratoryProcedureAbsoluteNeutrophilCountResultSpecifiedValue

Datatyp

double

Måttenheter
  • ul
ul
Platelet count (number/uL): (Transfusion Independent)
Beskrivning

LaboratoryProcedurePlateletResultSpecifiedValue

Datatyp

double

Måttenheter
  • 1000/uL
1000/uL
Hemoglobin(g/dL) (May receive RBC transfusion)
Beskrivning

LaboratoryProcedureHemoglobinResultSpecifiedValue

Datatyp

double

Måttenheter
  • g/dL
g/dL
Elig - Block 5
Beskrivning

Elig - Block 5

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

LaboratoryProcedureCreatinineClearanceOutcomeValue

Datatyp

double

Radioisotope GFR(mL/min/1.73 m²)
Beskrivning

LaboratoryProcedureGlomerularFiltrationRateOutcomeSpecifiedValue

Datatyp

double

Måttenheter
  • 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)
Beskrivning

LaboratoryProcedureCreatinineResultSpecifiedValue

Datatyp

double

Måttenheter
  • mg/dL
mg/dL
Elig - Block 7
Beskrivning

Elig - Block 7

Total bilirubin (mg/dl), ULN
Beskrivning

LaboratoryProcedureTotalBilirubinResultSpecifiedUpperLimitofNormalValue

Datatyp

double

Måttenheter
  • mg/dL
mg/dL
Total bilirubin Value (mg/dl):
Beskrivning

LaboratoryProcedureTotalBilirubinResultValue

Datatyp

double

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

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

Datatyp

double

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

LaboratoryProcedureAlanineAminotransferaseMeasurementAspartateAminotransferaseMeasurementOutcomeValue

Datatyp

double

Elig - Block 8
Beskrivning

Elig - Block 8

Does patient have seizure disorder?
Beskrivning

PatientSeizureDiseaseorDisorderInd-3

Datatyp

text

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

NeurologicalEvaluationSeizureSymptomInd-2

Datatyp

text

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

PatientMechanicalVentilationUseInd-2

Datatyp

text

Elig - Block 9
Beskrivning

Elig - Block 9

Does patient have mature teratoma with normal tumor markers?
Beskrivning

PatientCentralNervousSystemGermCellTumorDiagnosisInd-2

Datatyp

text

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

ExternalBrainVentricleCentralNervousSystemGermCellTumorDiagnosisInd-2

Datatyp

text

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

MetastaticDiseaseorDisorderMagneticResonanceImagingCerebrospinalFluidDiagnosisInd-2

Datatyp

text

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

SurgicalInterventionCorticosteroidAdministeredInd-2

Datatyp

text

Is patient post menarcheal?
Beskrivning

PediatricEndocrineMensesOnsetInd-2

Datatyp

text

Was a pregnancy test performed?
Beskrivning

PatientPregnancyTestIndicator

Datatyp

text

Is patient pregnant? (If yes above,)
Beskrivning

PatientPregnancyInd-2

Datatyp

text

Is patient nursing?
Beskrivning

PersonBreastFeedingExclusionCriteriaIndicator

Datatyp

text

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

BreastFeedingStopAgreementInd-4

Datatyp

text

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

ContraceptionAgreementInd

Datatyp

text

Elig - Block 10
Beskrivning

Elig - Block 10

Date Informed Consent Signed
Beskrivning

InformedConsentFormSignedDate

Datatyp

date

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

StudyCompleteRequirementsInd-2

Datatyp

text

Comments
Beskrivning

ResearchCommentsText

Datatyp

text

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Similar models

No Instruction available.

1 Formulär
  1. StudyEvent: SE.0000
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
TUMOR LOCATION 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
TUMOR LOCATION 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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