Evaluation of the Correlation Between Molecular Phenotype and Radiological Signature (by PET-scanner and MRI) of Incident WHO II and III Grade Gliomas.
July 2, 2024 updated by: GCS Ramsay Santé pour l'Enseignement et la Recherche
Evaluation of the Correlation Between Molecular Phenotype and Radiological Signature (by PET-scanner and MRI) of WHO II and III Grade Incident Gliomas.
From the medical records of a series of patients operated on for incident grade II and III glioma, the primary objective is to evaluate the correlation between the molecular profile of tumours and preoperative imaging data (by FDG and FDOPA PET-scan and multimodal MRI).
Study Overview
Detailed Description
A retrospective monocentre study of medical data (clinical, histological, molecular and imaging) contained in the medical records of patients operated on for Grade II or III incident glioma.
Study Type
Observational
Enrollment (Actual)
22
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, 13009
- Hopital Prive Clairval
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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
Sampling Method
Non-Probability Sample
Study Population
The study population represents the totality of patients with a glioma surgery in the centre between February 2015 and May 2019, with a complete and usable medical file.
Description
Inclusion Criteria:
- Subject 18 years of age or older, having been informed of the research
- Subject operated on with an incident glioma of grade II or III, histologically confirmed (WHO 2016 classification)
- Subject for which all preoperative imaging data is available (MRI, FDG and FDOPA PET-scan)
- Subject for which molecular data of the lesion are available
Exclusion Criteria:
- Subject having signified his opposition to the use of his medical data
- Subject under safeguard of justice, guardianship or trusteeship
- Subject with incomplete or missing part of the molecular and/or imaging data
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Cohort
Retrospective cohort
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Evaluate the correlation between tumour molecular profile and preoperative imaging data (FDG and FDOPA PET-scan and multimodal MRI).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary outcome
Time Frame: 4 years
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Evaluate the correlation between tumour molecular profile and preoperative imaging data (FDG and FDOPA PET-scan and multimodal MRI).
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4 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Molecular profile
Time Frame: 4years
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Evaluate the overall survival and progression-free survival of patients based on the molecular profile of gliomas.
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4years
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Imaging data
Time Frame: 4 years
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To evaluate the overall survival and progression-free survival of patients based on imaging data (PET-scan and MRI) of gliomas.
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4 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, MD PD, Hopital Prive Clairval
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 (Actual)
September 30, 2019
Primary Completion (Actual)
June 30, 2024
Study Completion (Actual)
June 30, 2024
Study Registration Dates
First Submitted
July 2, 2020
First Submitted That Met QC Criteria
July 2, 2020
First Posted (Actual)
July 8, 2020
Study Record Updates
Last Update Posted (Actual)
July 3, 2024
Last Update Submitted That Met QC Criteria
July 2, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RadioGLioSign
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.