Genetic and Molecular Characterization of Nervous System Lesions

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT06314607
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Prospective Biological Collection — GENETIC
    All samples that can be collected at each visit : * Saliva sampling (added by the research) * Collection of 2 to 4 additional tubes of blood (maximum 56mL) (added by the research if blood sampling in routine care) * Urine and stool samples (added by the research) * CSF sample residues (added by the research if lumbar punction in routine care) * Lesion sample residues and surgical waste fragments (added by the research if surgery in routine care)
  • Retrospective Biological Collection — GENETIC
    Requalification of all biological samples obtained as part of ONCONEUROTEK research, with patient consent (blood, saliva, urine, Stool, CSF, lesion sample and surgical waste fragments)

Study Details

Primary and secondary brain tumors, the leading cause of death from cancer before the age of 35, represent a complex and heterogeneous group of pathologies with a generally poor prognosis. Knowledge of these tumors has made enormous strides thanks to access to biological samples, leading to a much more robust, reliable and precise histo-pronostic classification, but also, increasingly, to the identification of theranostic targets. Despite these advances, there is a real need to refine diagnostic and prognostic classification, identify the biological mechanisms involved in the formation and progression of these pathologies, develop new targeted strategies, and devise minimally invasive follow-up methods (liquid biopsies). In addition, certain non-tumoral brain lesions (e.g. malformations) can be similarly classified according to their molecular and mutational profile. This project aims to make a decisive contribution to these objectives.

Key Dates

First listed
Mar 18, 2024
Start date
Mar 26, 2024
Status verified
Aug 2024
Primary completion
Mar 31, 2034
Completion
Mar 31, 2034

Study Design

Enrollment
10,000 participants (estimated)

Arms

  • Arm: Group 1
    Patients already included in the first ONCONEUROTEK (retrospective) study and followed up in the participating center : at their next hospitalization or consultation at Pitié Salpêtrière, they will be given an information note and a consent form (NIFC) informing them of the ONCONEUROTEK 2 study. (This population concerns all patients in the relevant departments with a last news date \< 2 years)
  • Arm: Group 2
    Patients included prospectively : Patients who may be included in this study will be informed of its objectives and procedures by the doctor in charge of their follow-up, during a consultation visit or routine hospitalization, by means of an information note. (This population concerns around 1,000 patients per year, i.e. around 10,000 patients over 10 years)
  • Arm: Group 3
    This group concerns patients already included in the ONCONEUROTEK study (retrospective) but not currently being followed at the Pitié Salpêtrière hospital. Specifically, patients who are known to the investigators to still be alive. In this case, an information note and a non-opposition form (NINO) will be sent to them by mail to : * inform them of the regulatory update under the Loi Jardé and the RGPD * and collect their non-opposition to the re-use of their data and samples. * If no reply is received within one month, the patient will be deemed not to have objected to the re-use of his or her data and samples in the ONCONEUROTEK 2 study. (This population concerns all patients in the relevant departments with a last news date \> 2 years)

Primary Outcome Measure

Study the clinical markers with the evolution of brain lesions. [ Time Frame: 10 years ]

Central Contacts

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