Multiomic Approach to Radioresistance of Ependymomas in Children and Adolescents

NCT05151718 | Recruiting

• 1 other identifier: 21 HLTETE 01
• Study Type: observational
• Target: 370
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment of childhood ependymoma, the second most frequent pediatric brain tumor, is based on surgery and radiation therapy. However, 50% relapse, mainly locally. Progress in imaging, molecular biology and radiotherapy ballistics has led us to propose the EPENDYMOMICS project, a multi-omics approach using artificial intelligence to detect the predictive characteristics of relapse, and to define innovative radiotherapy targets using multimodal imaging. We previously reported that the relapse sites are mainly located in the high-dose radiotherapy zone and that there appear to be prognostic factors for relapse based on anatomical and functional MRI abnormalities by diffusion and perfusion. In addition, recent studies in molecular biology have identified significant prognostic factors. The challenge now is to use and correlate all these findings in larger cohorts to tackle the radio-resistance of this disease. Our objective is to collate in a single database called NETSPARE (Network to Structure and Share Pediatric data to Accelerate Research on Ependymoma) the clinical, histological, biological, imaging and radiotherapy data from two consecutive studies that included 370 children and adolescents with ependymoma since 2000 in France. The EPENDYMOMICS project will comprise a clinical research team, three imaging research teams, two histopathology teams, and a biostatistics team working on NETSPARE. Our goal is to obtain a radiogenomic signature of our data, which will be validated with the English external cohort of 200 patients that is currently being analyzed. The perspective is to optimize the indications and volumes of irradiation that could in the future be used in a European translational research trial to tackle radioresistance.

Conditions

Ependymoma of Brain; Pediatric Solid Tumor

Keywords

childhood ependymoma; radio-resistance; radiogenomic signature

Outcome Measures

Primary Outcomes (1)

• Definition of radiogenomics signatures that are predictive of patient outcome

  The primary endpoint is progression-free survival (PFS), i.e. the time from diagnosis to progression or death from any cause. Patients alive at last follow-up are censored at this date.

  30 months

Secondary Outcomes (2)

• Definition of new RT target volumes based on radiomic features and to choose their indications based on biomolecular prognostic factors

  30 months

• To predict resistance to therapy by using the histological data in digital format and the biomolecular data for analysis by methods based on artificial deep neural networks .

  30 months

Eligibility Criteria

• Age: Up to 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with intracranial ependymoma treated in France since 2000 (included in PEPPI study between 2000 and 2013 and in pediaRT and french SIOP II programme since 2013)

You may qualify if:

• children with intracranial ependymoma
• treated
• included in PEPPI study, pediaRT or in SIOP II Ependymoma french program

Sponsors & Collaborators

• Institut Claudius Regaud: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Centre Leon Berard: collaborator
• Assistance Publique Hopitaux De Marseille: collaborator
• Centre Hospitalier St Anne: collaborator
• Institut Pasteur: collaborator

Study Sites (1)

Institut Claudius Regaud

Toulouse, 31059, France

RECRUITING

Related Publications (32)

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Biospecimen

Retention: SAMPLES WITH DNA

FFPE sample of each patient tumor is included in the PEPPI cohort to Marseille is stored in the AP-HM tumor bank (AP-HM CRB-TBM (Centre de Ressources Biologiques - Tumorothèque et Banque de Muscle - CRB BB-0033-00097) headed by Prof D. Figarella-Branger, certified Afnor 96900 and ISO 9001 (AC-2018-3105) until use.

MeSH Terms

Conditions

Familial ependymoma

Central Study Contacts

Anne LAPRIE, PU-PH

CONTACT

+ 33 (0)5 31 15 50 50; laprie.anne@iuct-oncopole.fr

Fatima TENSAOUTI, phD

CONTACT

+ 33 (0)5 31 15 50 50; tensaouti.fatima@iuct-oncopole.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 9, 2021
• Study Start: September 30, 2021
• Primary Completion: August 31, 2025
• Study Completion: September 30, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)