Pediatric Solid Tumor Clinical Trial
— EPENDYMOMICSOfficial title:
Ependymomics: Multiomic Approach to Radioresistance of Ependymomas in Children and Adolescents
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.
Status | Recruiting |
Enrollment | 370 |
Est. completion date | September 29, 2024 |
Est. primary completion date | October 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 25 Years |
Eligibility | Inclusion Criteria: - children with intracranial ependymoma - treated - included in PEPPI study, pediaRT or in SIOP II Ependymoma french program Exclusion Criteria: - NA |
Country | Name | City | State |
---|---|---|---|
France | Institut Claudius Regaud | Toulouse |
Lead Sponsor | Collaborator |
---|---|
Institut Claudius Regaud | Assistance Publique Hopitaux De Marseille, Centre Hospitalier St Anne, Centre Leon Berard, Institut National de la Santé Et de la Recherche Médicale, France, Institut Pasteur |
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* Note: There are 32 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | 30 months | |
Secondary | 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 | 30 months |
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