NCT04614480: EXOMA2

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

Recruiting now Phase 2 Last updated 22 September 2025

What this trial tests

Phase 2 trial testing Exome analysis in Cancer in 7,976 participants. Currently enrolling.

Timeline

25 August 2020

Primary endpoint
2 September 2028

2 September 2032

Quick facts

Lead sponsor	Centre Georges Francois Leclerc
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	7,976
Start date	25 August 2020
Primary completion	2 September 2028
Estimated completion	2 September 2032
Sites	12 locations across France

Drugs / interventions tested

• Exome analysis

Conditions studied

• Cancer — all drugs for Cancer →

Sponsor

Centre Georges Francois Leclerc — full company profile →

Who can join

18 and older, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. FGF/FGFR genomic amplification as a predictive biomarker for immune checkpoint blockade resistance: a short report.
   Roussot N, Lecuelle J, Dalens L, Truntzer C, et al · · 2023 · cited 5× · PMID 37890888 · DOI 10.1136/jitc-2023-007763
2. Exome-Based Genomic Markers Could Improve Prediction of Checkpoint Inhibitor Efficacy Independently of Tumor Type.
   Dalens L, Lecuelle J, Favier L, Fraisse C, et al · · 2023 · cited 3× · PMID 37108755 · DOI 10.3390/ijms24087592
3. Targeting mTOR signaling for the treatment of intrahepatic cholangiocarcinoma with TSC1/ARID1A mutations: a case report with an unexpected response.
   Daugan C, Boidot R, Ghiringhelli F, Borg C, et al · · 2024 · cited 2× · PMID 39281970 · DOI 10.1177/17588359241271793
4. Clinical Interest in Exome-Based Analysis of Somatic Mutational Signatures for Non-Small Cell Lung Cancer.
   Peroz M, Mananet H, Roussot N, Kaderbhai CG, et al · · 2024 · PMID 39272973 · DOI 10.3390/cancers16173115