Multiomic Approach to Radioresistance of Ependymomas in Children and Adolescents

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 25
SponsorInstitut Claudius Regaud

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

children with intracranial ependymoma

treated

included in PEPPI study, pediaRT or in SIOP II Ependymoma french program

Disqualifiers

NA

Trial 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)

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
30 months

Secondary outcomes

1

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

Several indexes will be used to evaluate discriminant capacity: Harrell's C-Index and the D statistics, Akaike Information Criterion (AIC) and the RD² statistic

Time frame
30 months
2

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 .

Several indexes will be used to evaluate discriminant capacity: Harrell's C-Index and the D statistics, Akaike Information Criterion (AIC) and the RD² statistic

Time frame
30 months

Other outcomes

Sponsors and contacts

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Institut Claudius Regaud

Lead sponsor

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