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Evaluation of the Correlation Between Molecular Phenotype and Radiological Signature (by PET-scanner and MRI) of Incident WHO II and III Grade Gliomas.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04461002
Recruitment Status : Enrolling by invitation
First Posted : July 8, 2020
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
GCS Ramsay Santé pour l’Enseignement et la Recherche

Brief Summary:
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).

Condition or disease Intervention/treatment
Glioma Other: Retrospective analysis

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.

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Evaluation of the Correlation Between Molecular Phenotype and Radiological Signature (by PET-scanner and MRI) of WHO II and III Grade Incident Gliomas.
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cohort
Retrospective cohort
Other: Retrospective analysis
Evaluate the correlation between tumour molecular profile and preoperative imaging data (FDG and FDOPA PET-scan and multimodal MRI).




Primary Outcome Measures :
  1. Primary outcome [ Time Frame: 4 years ]
    Evaluate the correlation between tumour molecular profile and preoperative imaging data (FDG and FDOPA PET-scan and multimodal MRI).


Secondary Outcome Measures :
  1. Molecular profile [ Time Frame: 4years ]
    Evaluate the overall survival and progression-free survival of patients based on the molecular profile of gliomas.

  2. Imaging data [ Time Frame: 4 years ]
    To evaluate the overall survival and progression-free survival of patients based on imaging data (PET-scan and MRI) of gliomas.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04461002


Locations
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France
Hôpital Privé Clairval
Marseille, France, 13009
Sponsors and Collaborators
GCS Ramsay Santé pour l’Enseignement et la Recherche
Investigators
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Principal Investigator: Philippe METELLUS, MD PD Hôpital Privé Clairval
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Responsible Party: GCS Ramsay Santé pour l’Enseignement et la Recherche
ClinicalTrials.gov Identifier: NCT04461002    
Other Study ID Numbers: RadioGLioSign
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue