ID

4503

Beschrijving

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=

Trefwoorden

Versies (2)
  1. 09-12-13 09-12-13 - Martin Dugas
  2. 02-06-15 02-06-15 -
Geüploaded op

9 december 2013

DOI

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Creative Commons BY-NC 3.0 Legacy
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ACNS1123 Eligibility - 3377519v1.0

Engels

No Instruction available.

1 Formulieren  
  1. StudyEvent: SE.0000
    1. No Instruction available.
Stratification
Beschrijving

Stratification

ACNS1123 Stratum
Beschrijving

ClinicalStudyACNS1123StratificationFactorsType

Datatype

text

Study Treatment
Beschrijving

TreatmentAssignmentType

Datatype

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.)
Beschrijving

TreatmentBeginDate

Datatype

date

Elig - Block 1
Beschrijving

Elig - Block 1

Is the patient enrolled on the ALTE07C1 study?
Beschrijving

OtherStudyEnrollmentInd-2

Datatype

text

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

PatientAgeEligibilityDeterminationInd-2

Datatype

text

Was definitive diagnostic surgery performed?
Beschrijving

FirstDiagnosisFromSurgicalProcedureIndicator

Datatype

text

Date of definitive diagnostic surgery or clinical diagnosis:
Beschrijving

PersonSuspectedClinicalDiagnosisEligibilityCriteriaDate

Datatype

date

Was lumbar CSF cytology obtained?
Beschrijving

CerebrospinalFluidCellInd-3

Datatype

text

Was it medically contraindicated? (If no,)
Beschrijving

CerebrospinalFluidDiagnosticProcedureCytologyContraindicatedInd-2

Datatype

text

Was lumbar CSF cytology negative?
Beschrijving

LaboratoryProcedureLumbarPunctureCerebrospinalFluidNegativeFindingOutcomeInd-2

Datatype

text

Elig - Block 2
Beschrijving

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)
Beschrijving

GermCellTumorHistologicClassificationDiagnosisInd-2

Datatype

text

Elig - Block 3
Beschrijving

Elig - Block 3

Does patient have newly diagnosed localized primary CNS NGGCT?
Beschrijving

NewPrimaryMalignantNeoplasmCentralNervousSystemGermCellTumorDiagnosisInd-2

Datatype

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)
Beschrijving

PathologyFindingsIndicator

Datatype

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.)
Beschrijving

PatientProtocolRequirementEligibilityDeterminationInd-2

Datatype

text

Elig - Block 4
Beschrijving

Elig - Block 4

Does patient have newly diagnosed localized primary CNS germinoma?
Beschrijving

NewChildhoodBrainGerminomaDiagnosisInd-2

Datatype

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.)
Beschrijving

PatientProtocolRequirementEligibilityDeterminationInd-2

Datatype

text

Elig - Block 5
Beschrijving

Elig - Block 5

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

LaboratoryProcedureAbsoluteNeutrophilCountResultSpecifiedValue

Datatype

double

Maateenheden
  • ul
ul
Platelet count (number/uL): (Transfusion Independent)
Beschrijving

LaboratoryProcedurePlateletResultSpecifiedValue

Datatype

double

Maateenheden
  • 1000/uL
1000/uL
Hemoglobin(g/dL) (May receive RBC transfusion)
Beschrijving

LaboratoryProcedureHemoglobinResultSpecifiedValue

Datatype

double

Maateenheden
  • g/dL
g/dL
Elig - Block 5
Beschrijving

Elig - Block 5

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

LaboratoryProcedureCreatinineClearanceOutcomeValue

Datatype

double

Radioisotope GFR(mL/min/1.73 m²)
Beschrijving

LaboratoryProcedureGlomerularFiltrationRateOutcomeSpecifiedValue

Datatype

double

Maateenheden
  • 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)
Beschrijving

LaboratoryProcedureCreatinineResultSpecifiedValue

Datatype

double

Maateenheden
  • mg/dL
mg/dL
Elig - Block 7
Beschrijving

Elig - Block 7

Total bilirubin (mg/dl), ULN
Beschrijving

LaboratoryProcedureTotalBilirubinResultSpecifiedUpperLimitofNormalValue

Datatype

double

Maateenheden
  • mg/dL
mg/dL
Total bilirubin Value (mg/dl):
Beschrijving

LaboratoryProcedureTotalBilirubinResultValue

Datatype

double

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

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

Datatype

double

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

LaboratoryProcedureAlanineAminotransferaseMeasurementAspartateAminotransferaseMeasurementOutcomeValue

Datatype

double

Elig - Block 8
Beschrijving

Elig - Block 8

Does patient have seizure disorder?
Beschrijving

PatientSeizureDiseaseorDisorderInd-3

Datatype

text

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

NeurologicalEvaluationSeizureSymptomInd-2

Datatype

text

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

PatientMechanicalVentilationUseInd-2

Datatype

text

Elig - Block 9
Beschrijving

Elig - Block 9

Does patient have mature teratoma with normal tumor markers?
Beschrijving

PatientCentralNervousSystemGermCellTumorDiagnosisInd-2

Datatype

text

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

ExternalBrainVentricleCentralNervousSystemGermCellTumorDiagnosisInd-2

Datatype

text

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

MetastaticDiseaseorDisorderMagneticResonanceImagingCerebrospinalFluidDiagnosisInd-2

Datatype

text

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

SurgicalInterventionCorticosteroidAdministeredInd-2

Datatype

text

Is patient post menarcheal?
Beschrijving

PediatricEndocrineMensesOnsetInd-2

Datatype

text

Was a pregnancy test performed?
Beschrijving

PatientPregnancyTestIndicator

Datatype

text

Is patient pregnant? (If yes above,)
Beschrijving

PatientPregnancyInd-2

Datatype

text

Is patient nursing?
Beschrijving

PersonBreastFeedingExclusionCriteriaIndicator

Datatype

text

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

BreastFeedingStopAgreementInd-4

Datatype

text

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

ContraceptionAgreementInd

Datatype

text

Elig - Block 10
Beschrijving

Elig - Block 10

Date Informed Consent Signed
Beschrijving

InformedConsentFormSignedDate

Datatype

date

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

StudyCompleteRequirementsInd-2

Datatype

text

Comments
Beschrijving

ResearchCommentsText

Datatype

text

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Similar models

No Instruction available.

1 Formulieren
  1. StudyEvent: SE.0000
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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