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Informations:
Erreur:
ID
4503
Description
ACNS1123 Eligibility Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=
Lien
https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=
Mots-clés
Versions (2)
- 09/12/2013 09/12/2013 - Martin Dugas
- 02/06/2015 02/06/2015 -
Téléchargé le
9 décembre 2013
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0 Legacy
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ACNS1123 Eligibility - 3377519v1.0
No Instruction available.
- StudyEvent: SE.0000
Similar models
No Instruction available.
- StudyEvent: SE.0000
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
CL Item
Stratum 1 - Nggct (Stratum 1 - NGGCT)
CL Item
Stratum 2 - Germinoma (Stratum 2 - Germinoma)
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
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
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)
CL Item
Yes (Yes)
CL Item
No (No)
PersonSuspectedClinicalDiagnosisEligibilityCriteriaDate
Item
Date of definitive diagnostic surgery or clinical diagnosis:
date
CL Item
Yes (Yes)
CL Item
No (No)
Item
Was it medically contraindicated? (If no,)
text
CL Item
Yes (Yes)
CL Item
No (No)
Item
Was lumbar CSF cytology negative?
text
CL Item
Yes (Yes)
CL Item
No (No)
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
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
Does patient have newly diagnosed localized primary CNS NGGCT?
text
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
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
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 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
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
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
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 Item
Yes (Yes)
CL Item
No (No)
Item
Does patient have mature teratoma with normal tumor markers?
text
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does patient have tumors located outside the ventricles? (basal ganglia, thalamus)
text
CL Item
Yes (Yes)
CL Item
No (No)
Item
Does patient have metastatic disease by either MRI evaluation or lumbar CSF cytology?
text
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
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)
CL Item
Yes (yes)
CL Item
No (no)
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Yes (Yes)
CL Item
No (No)
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
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)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed
date
Item
Have all institutional, FDA, and NCI requirements for human studies been met?
text
CL Item
Yes (Yes)
CL Item
No (No)
ResearchCommentsText
Item
Comments
text