Molecular Heterogeneity in Multilobar Low-grade Gliomas

• Conditions: Low-grade Diffuse Glioma

• Registration Number: NCT04000048
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Low-grade diffuse glioma (GDBG) are rare tumors of young adults, whose ontogenesis is poorly understood. Patient management is based on the molecular profile defined by two molecular markers : mutations of the IDH genes and chromosomal 1p19q co-deletion. To date, the IDH and 1p19q statuses are determined on a single fragment collected from the tumor. In the case of GDBGs infiltrating several brain lobes, the sampling is done randomly on only one of the infiltrated lobes. An intra-tumoral heterogeneity of genetic alterations has been suggested and would impact management.

Phylogenetic analysis of genetic alterations found, by high throughput sequencing, in each lobe invaded by the same GDBG will make it possible to assess intra-tumoral heterogeneity and to discuss, at a fundamental level, the hypothesis of a single tumor site with secondary diffusion or that of the convergent progression of two or three distinct tumor sites. Clinically, understanding the ontogenesis of GDBGs will improve their management because of the known link between brain location, dominant molecular profile, and prognosis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-06
• Study Start: 2019-06-24
• Study First Submitted: 2019-06-25
• Study First Submitted QC: 2019-06-25
• Study First Posted: 2019-06-27
• Last Update Submitted: 2019-12-02
• Last Update Posted: 2019-12-03
• Primary Completion: 2020-06
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Be over 18 years old.
• Subject not opposed to participating in the study
• Be scheduled in the operating room for the first surgery of a low-grade diffuse glioma presupposition on the basis of clinical and imaging criteria.
• Confirmation, after histopathological analysis of the resected tumor fragments, of the diagnosis of grade II glioma according to the 2016 WHO classification of brain tumors.

Exclusion Criteria

• Patient minor, or major under legal protection, or unable to give consent.
• Refusal to participate in the study.
• Pathology diagnosis of grade III glioma according to WHO 2016 classification
• Have received oncology treatment (chemotherapy and or chemotherapy) before the first surgery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Genetic profile	12 month	exhaustive high throughput sequencing of each of the 3 infiltrated lobes, followed by comparative phylogenetic analysis of the genetic profiles obtained in the 3 locations

Trial Locations

Locations (1)

CHU Gui de Chauliac; 🇫🇷 Montpellier, France