- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00920335
Adult Intracranial Ependymoma
February 24, 2014 updated by: Assistance Publique Hopitaux De Marseille
Adult Intracranial Ependydomas : Prognostic and Diagnostic Factors Assessment and Molecular Characterization
Adult intracranial ependymoma is a relatively rare brain tumour entity, accounting for 2-5% of all intracranial neoplasms.
The pertinent prognostic factors as well as the pattern of recurrence remain to be elucidated.
According to several recent reports, the prognostic value of Karnofski performance status, tumour location, the extent of surgical removal, histological grade and even postoperative radiotherapy remain controversial.
As a consequence, optimal therapeutic management of adult intracranial ependymomas remains an ongoing debate.
For this reason, a retrospective study conducted by the French society of neurosurgery (SFNC), neuropathology (SFNP) and the association of the neuro-oncologists of French expression (ANOCEF) was undertaken and allowed to collect 258 cases coming from 25 centers, initially diagnosed as intracranial ependymomas between 1990 and 2004.
Clinical and follow-up data of these patients are known and the paraffin embedded samples as well as the frozen tissues available have been centralized.
Central pathological review of these 258 cases was conducted by two senior neuropathologists and confirmed the diagnosis of ependymoma in 152 cases, thus constituting the most important series of the literature.
Few molecular studies were carried out on ependymomas.
The investigators have the opportunity, based on this important series, to determine the clinicopathological criteria and the molecular markers who will allow a better characterization of the diagnosis and the prognosis of these tumors.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
192
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Marseille, France
- Assistance Publique Hopitaux de Marseille
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis later(posterior) than January, 1990
- Diagnosis previous to June, 2004
- Available postoperative MRI at the not dead patients during operating
- Diagnosis of EICA held(retained) after centralized second reading
- Absence of histories of radiotherapy and\or chemotherapy for a brain damage
Exclusion Criteria:
- Diagnosis previous to January, 1990
- Diagnosis later(posterior) than June, 2004 ·
- Diagnosis of EICA not held(retained) after centralized second reading
- Histories of radiotherapy and\or chemotherapy for a brain damage
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary objective is to identify a gene expression pattern associated with recurrence in adult intracranial ependymomas.
Time Frame: 3 years
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3 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Firstly to identify reliable molecular markers of the diagnosis of adult intracranial ependymomas and, secondly, to seek a molecular signature selectively expressed in sub-groups of ependymomas according to topography, age and histological grading.
Time Frame: 3 years
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3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: philippe METELLUS, Assistance Publique Hopitaux de Marseille
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (ACTUAL)
July 1, 2013
Study Completion (ACTUAL)
July 1, 2013
Study Registration Dates
First Submitted
May 4, 2009
First Submitted That Met QC Criteria
June 12, 2009
First Posted (ESTIMATE)
June 15, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
February 25, 2014
Last Update Submitted That Met QC Criteria
February 24, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008-25
- 2008-A01289-46
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intracranial Ependymoma
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National Taiwan University HospitalWithdrawnGlioblastoma Multiforme | Anaplastic Ependymoma | Anaplastic Astrocytomas | Anaplastic Oligodendrogliomas | Malignant Intracranial TumorsTaiwan
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Children's Oncology GroupNational Cancer Institute (NCI)Active, not recruitingEpendymoma | Anaplastic Ependymoma | Clear Cell Ependymoma | Brain Ependymoma | Cellular Ependymoma | Papillary EpendymomaUnited States, Canada, Australia, New Zealand
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Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Infratentorial Ependymoma | Childhood Supratentorial Ependymoma | Newly Diagnosed Childhood EpendymomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingEpendymoma | Anaplastic EpendymomaUnited States
-
Ann & Robert H Lurie Children's Hospital of ChicagoNorthwestern UniversityTerminatedGlioblastoma Multiforme | Ependymoma | Anaplastic Ependymoma | Astrocytoma, Grade III | Clear Cell EpendymomaUnited States
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National Cancer Institute (NCI)TerminatedEpendymoma | Anaplastic Ependymoma | EpendymomasUnited States
-
National Cancer Institute (NCI)CompletedEpendymoma | Anaplastic EpendymomaUnited States
-
National Cancer Institute (NCI)TerminatedAdult Anaplastic Astrocytoma | Adult Anaplastic Ependymoma | Adult Anaplastic Oligodendroglioma | Adult Diffuse Astrocytoma | Adult Ependymoma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Adult Mixed Glioma | Adult Myxopapillary Ependymoma | Adult Oligodendroglioma | Adult Pilocytic... and other conditionsUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingAdult Anaplastic Astrocytoma | Adult Anaplastic Ependymoma | Adult Anaplastic Oligodendroglioma | Adult Diffuse Astrocytoma | Adult Ependymoma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Adult Mixed Glioma | Adult Myxopapillary Ependymoma | Adult Oligodendroglioma | Adult Pilocytic... and other conditionsUnited States
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Rush University Medical CenterAxelar ABTerminatedGlioblastoma | Gliosarcoma | Anaplastic Oligoastrocytoma | Anaplastic Astrocytoma | Anaplastic Ependymoma | Anaplastic OligodendrogliomaUnited States
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