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NCT Number: NCT04614480

Exome Analysis (Complexe vs Simple) 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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Amiens Picardie, Amiens, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Exome analysis

Genetic

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

Primary outcomes

proportion of patients for whom therapy was initiated from informations of the "complex" exome analysis

Time frame: inclusion

Study contacts

Contact information is provided by the study sponsor or research team.

Emilie Rederstorff, PhD

CONTACT

[email protected]

+33(0)3 80 73 75 00 ext. 34 61

François Ghiringhelli, PU-PH

CONTACT

[email protected]

+33(0)3 80 73 75 00

Sponsors and collaborators

Lead sponsor

Centre Georges Francois Leclerc

Other

Registry information

Official study 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

Acronym: EXOMA2

Important dates

Study start: 2020
Primary completion: 2028
Study completion: 2032
First posted: Nov 4, 2020
Registry last updated: Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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