Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04614480

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

Led by Centre Georges Francois Leclerc · Updated on 2025-09-22

7976

Participants Needed

12

Research Sites

627 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Weight greater than 30 kg
  • Histological or cytological diagnosis of metastatic or locally advanced solid tumor
  • Patient in first line of treatment for metastatic or locally advanced disease
  • Tumor material available in sufficient and usable quantity for study analyses
  • Request for exome analysis at initiation of first or second line of treatment
  • Life expectancy estimated to be at least 6 months
  • WHO performance status less than or equal to 1
  • Patient capable and willing to follow all study procedures
  • Patient has signed informed consent
  • Patient affiliated with social security scheme
Not Eligible

You will not qualify if you...

  • Tumor material not available or biopsy not possible
  • Unable to have a blood test
  • Refusal of genetic analysis
  • Likely disease progression within 3 months of study inclusion
  • History of HIV, HBV, or HCV infection
  • Already included in EXOMA or EXOMA2 study
  • Woman who is pregnant, possibly pregnant, or breastfeeding
  • Persons deprived of liberty or under guardianship (including curatorship)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 12 locations

1

CHU Amiens Picardie

Amiens, France

Not Yet Recruiting

2

CHRU Jean Minjoz

Besançon, France

Actively Recruiting

3

Institut Bergonie

Bordeaux, France

Terminated

4

Centre Henri Baclesse

Caen, France

Actively Recruiting

5

CGFL

Dijon, France, 21079

Actively Recruiting

6

CHU François Mitterrand

Dijon, France

Actively Recruiting

7

Institut Hospitalier Franco-Britannique

Levallois-Perret, France

Terminated

8

Centre Oscar Lambret

Lille, France

Actively Recruiting

9

CHU Nantes

Nantes, France

Terminated

10

Chu Poitiers

Poitiers, France

Terminated

11

Institut JeanGodinot

Reims, France

Actively Recruiting

12

Centre Eugène Marquis

Rennes, France

Actively Recruiting

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Research Team

F

François Ghiringhelli, PU-PH

CONTACT

E

Emilie Rederstorff, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

14

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