ID

10452

Description

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=

Keywords

Versions (2)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 6/2/15 6/2/15 -
Uploaded on

June 2, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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ACNS1123 Eligibility

English

No Instruction available.

1 forms  
  1. StudyEvent: SE.0000
    1. No Instruction available.
Stratification
Description

Stratification

ACNS1123 Stratum
Description

ClinicalStudyACNS1123StratificationFactorsType

Data type

text

Study Treatment
Description

TreatmentAssignmentType

Data type

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.)
Description

TreatmentBeginDate

Data type

date

TUMOR LOCATION Elig - Block 1
Description

TUMOR LOCATION Elig - Block 1

Is the patient enrolled on the ALTE07C1 study?
Description

OtherStudyEnrollmentInd-2

Data type

text

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

PatientAgeEligibilityDeterminationInd-2

Data type

text

Was definitive diagnostic surgery performed?
Description

FirstDiagnosisFromSurgicalProcedureIndicator

Data type

text

Date of definitive diagnostic surgery or clinical diagnosis:
Description

PersonSuspectedClinicalDiagnosisEligibilityCriteriaDate

Data type

date

Was lumbar CSF cytology obtained?
Description

CerebrospinalFluidCellInd-3

Data type

text

Was it medically contraindicated? (If no,)
Description

CerebrospinalFluidDiagnosticProcedureCytologyContraindicatedInd-2

Data type

text

Was lumbar CSF cytology negative?
Description

LaboratoryProcedureLumbarPunctureCerebrospinalFluidNegativeFindingOutcomeInd-2

Data type

text

TUMOR LOCATION Elig - Block 2
Description

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)
Description

GermCellTumorHistologicClassificationDiagnosisInd-2

Data type

text

Elig - Block 3
Description

Elig - Block 3

Does patient have newly diagnosed localized primary CNS NGGCT?
Description

NewPrimaryMalignantNeoplasmCentralNervousSystemGermCellTumorDiagnosisInd-2

Data type

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)
Description

PathologyFindingsIndicator

Data type

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.)
Description

PatientProtocolRequirementEligibilityDeterminationInd-2

Data type

text

Elig - Block 4
Description

Elig - Block 4

Does patient have newly diagnosed localized primary CNS germinoma?
Description

NewChildhoodBrainGerminomaDiagnosisInd-2

Data type

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.)
Description

PatientProtocolRequirementEligibilityDeterminationInd-2

Data type

text

Elig - Block 5
Description

Elig - Block 5

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

LaboratoryProcedureAbsoluteNeutrophilCountResultSpecifiedValue

Data type

double

Measurement units
  • ul
ul
Platelet count (number/uL): (Transfusion Independent)
Description

LaboratoryProcedurePlateletResultSpecifiedValue

Data type

double

Measurement units
  • 1000/uL
1000/uL
Hemoglobin(g/dL) (May receive RBC transfusion)
Description

LaboratoryProcedureHemoglobinResultSpecifiedValue

Data type

double

Measurement units
  • g/dL
g/dL
Elig - Block 5
Description

Elig - Block 5

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

LaboratoryProcedureCreatinineClearanceOutcomeValue

Data type

double

Radioisotope GFR(mL/min/1.73 m²)
Description

LaboratoryProcedureGlomerularFiltrationRateOutcomeSpecifiedValue

Data type

double

Measurement units
  • 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)
Description

LaboratoryProcedureCreatinineResultSpecifiedValue

Data type

double

Measurement units
  • mg/dL
mg/dL
Elig - Block 7
Description

Elig - Block 7

Total bilirubin (mg/dl), ULN
Description

LaboratoryProcedureTotalBilirubinResultSpecifiedUpperLimitofNormalValue

Data type

double

Measurement units
  • mg/dL
mg/dL
Total bilirubin Value (mg/dl):
Description

LaboratoryProcedureTotalBilirubinResultValue

Data type

double

Measurement units
  • mg/dL
mg/dL
SGPT (ALT) or SGOT (AST) U/L, ULN:
Description

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

Data type

double

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

LaboratoryProcedureAlanineAminotransferaseMeasurementAspartateAminotransferaseMeasurementOutcomeValue

Data type

double

Elig - Block 8
Description

Elig - Block 8

Does patient have seizure disorder?
Description

PatientSeizureDiseaseorDisorderInd-3

Data type

text

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

NeurologicalEvaluationSeizureSymptomInd-2

Data type

text

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

PatientMechanicalVentilationUseInd-2

Data type

text

Elig - Block 9
Description

Elig - Block 9

Does patient have mature teratoma with normal tumor markers?
Description

PatientCentralNervousSystemGermCellTumorDiagnosisInd-2

Data type

text

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

ExternalBrainVentricleCentralNervousSystemGermCellTumorDiagnosisInd-2

Data type

text

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

MetastaticDiseaseorDisorderMagneticResonanceImagingCerebrospinalFluidDiagnosisInd-2

Data type

text

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

SurgicalInterventionCorticosteroidAdministeredInd-2

Data type

text

Is patient post menarcheal?
Description

PediatricEndocrineMensesOnsetInd-2

Data type

text

Was a pregnancy test performed?
Description

PatientPregnancyTestIndicator

Data type

text

Is patient pregnant? (If yes above,)
Description

PatientPregnancyInd-2

Data type

text

Is patient nursing?
Description

PersonBreastFeedingExclusionCriteriaIndicator

Data type

text

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

BreastFeedingStopAgreementInd-4

Data type

text

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

ContraceptionAgreementInd

Data type

text

Elig - Block 10
Description

Elig - Block 10

Date Informed Consent Signed
Description

InformedConsentFormSignedDate

Data type

date

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

StudyCompleteRequirementsInd-2

Data type

text

Comments
Description

ResearchCommentsText

Data type

text

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Similar models

No Instruction available.

1 forms
  1. StudyEvent: SE.0000
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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