Exome Analysis (Complexe vs Simple) to Help the Therapeutic Decision for the Precision Medicine (EXOMA2)

September 16, 2025 updated by: Centre Georges Francois Leclerc

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

7976

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France
      • Besançon, France
        • Recruiting
        • CHRU Jean Minjoz
        • Contact:
      • Bordeaux, France
        • Terminated
        • Institut Bergonie
      • Caen, France
      • Dijon, France
      • Dijon, France, 21079
        • Recruiting
        • CGFL
        • Contact:
      • Levallois-Perret, France
        • Terminated
        • Institut Hospitalier Franco-Britannique
      • Lille, France
        • Recruiting
        • Centre Oscar Lambret
        • Contact:
      • Nantes, France
        • Terminated
        • CHU Nantes
      • Poitiers, France
        • Terminated
        • CHU Poitiers
      • Reims, France
      • Rennes, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. Weight> 30 Kg
  3. Histological or cytological evidence of the diagnosis of a metastatic or locally advanced solid tumor
  4. Patient in 1st line of treatment for metastatic or locally advanced disease
  5. Tumor material available in sufficient and usable quantity for the analyzes required by the study
  6. Request for exome analysis to be carried out when initiating the 1st or 2nd line of treatment (line initiated at the time of inclusion)
  7. Life expectancy estimated to be probably ≥ 6 months.
  8. WHO ≤ 1
  9. Patient capable and willing to follow all study procedures in accordance with the protocol
  10. Patient having understood the purpose, risks and constraints of the study and having signed and dated the consent form
  11. Patient affiliated to the social security scheme.

Exclusion Criteria:

  1. Tumor material not available or biopsy not possible.
  2. Inability to take a blood test.
  3. Refusal of genetic analysis.
  4. Patient likely to progress within 3 months of inclusion in the study.
  5. History of HIV / HBV / HCV infection.
  6. Patient already included in the EXOMA or EXOMA2 study.
  7. Woman who is pregnant, may be, or is breastfeeding.
  8. Persons deprived of their liberty or under guardianship (including curatorship).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Metastatic breast cancers
Genetic: Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Other: Metastatic prostate cancers
Genetic: Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Other: Metastatic lung cancers
Genetic: Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Other: Metastatic colorectal cancers
Genetic: Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Other: metastatic otorhinolaryngeal cancer
Genetic: Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Other: metastatic ovarian cancer
Genetic: Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Other: Pancreatic cancers
Genetic: Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Other: Others metastatic cancers
Genetic: Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Other: Metastatic sarcoma
Genetic: Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Other: Metastatic gynecological cancer
Genetic: Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Other: Metastatic renal cancer
Genetic: Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Other: Metastatic cholangiocarcinoma metastatic
Genetic: Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Other: Metastatic digestive cancer (other than stomach and colorectal)
Genetic: Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Other: Metastatic stomach cancer
Genetic: Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
proportion of patients for whom therapy was initiated from informations of the "complex" exome analysis
Time Frame: inclusion
inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Georges Francois Leclerc

Investigators

  • Study Director: Charles Coutant, PU-PH, Centre Georges François Leclerc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2020

Primary Completion (Estimated)

September 2, 2028

Study Completion (Estimated)

September 2, 2032

Study Registration Dates

First Submitted

October 29, 2020

First Submitted That Met QC Criteria

October 29, 2020

First Posted (Actual)

November 4, 2020

Study Record Updates

Last Update Posted (Estimated)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A02135-52

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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