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RECRUITING
NCT04614480
PHASE2

Exome Analysis (Complexe vs Simple) to Help the Therapeutic Decision for the Precision Medicine

Sponsor: Centre Georges Francois Leclerc

View on ClinicalTrials.gov

Summary

The "simple" analysis of the exome can determine somatic and constitutional mutations. The major challenge lies in the translation of sequencing data into clinically relevant information allowing the clinician to guide his decision-making A "complex" analysis of the exome would provide access to structural DNA data, concerning mutational signatures, tumor mutational load, analysis of large deletions, loss of heterozygosity as well as amplification of certain genes which may have an impact on the management of patients. No data available to date makes it possible to assess the clinical interest of the availability of its additional information resulting from a "complex" analysis compared to a "simple" analysis. The objective of the EXOMA2 study is to assess the proportion of patients for whom the proposed therapy is derived from its additional information (complex analysis) and would not have been possible with a classic exome analysis (simple analysis) . We hereby formulate the hypothesis that a "complex" analysis on a population presenting a metastatic or locally advanced disease treated early (from the 1st line of treatment) will make it possible to determine therapeutic indications which could not be discovered with a "simple" analysis.

Official title: A Multicenter, Prospective, Multi-organ Study to Evaluate the Clinical Benefit of an Exome "Complex" Analysis Versus an Exome "Simple" Analysis to Help the Therapeutic Decision for the Precision Medicine

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

7976

Start Date

2020-08-25

Completion Date

2032-09-02

Last Updated

2025-09-22

Healthy Volunteers

No

Conditions

Interventions

GENETIC

Exome analysis

Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment

Locations (12)

CHU Amiens Picardie

Amiens, France

CHRU Jean Minjoz

Besançon, France

Institut Bergonie

Bordeaux, France

Centre Henri Baclesse

Caen, France

CGFL

Dijon, France

CHU François Mitterrand

Dijon, France

Institut Hospitalier Franco-Britannique

Levallois-Perret, France

Centre Oscar Lambret

Lille, France

CHU Nantes

Nantes, France

Chu Poitiers

Poitiers, France

Institut JeanGodinot

Reims, France

Centre Eugène Marquis

Rennes, France