ID

10452

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

2. Juni 2015

DOI

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ACNS1123 Eligibility

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

TUMOR LOCATION Elig - Block 1
Beschreibung

TUMOR LOCATION 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

TUMOR LOCATION Elig - Block 2
Beschreibung

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)
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
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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