Clinical trial NCT04614480: Exome Analysis (Complexe vs Simple) to Help the Therapeutic Decision for the Precision Medicine
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cancer
Keywords: genetic
exome
Lead sponsor: Centre Georges Francois Leclerc
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 2518
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: proportion of patients for whom therapy was initiated from informations of the "complex" exome analysis
timeFrame: inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
city: Besançon
country: France
facility: CHRU Jean Minjoz
city: Bordeaux
country: France
facility: Institut Bergonie
city: Dijon
country: France
facility: CGFL
city: Dijon
country: France
facility: CHU François Mitterrand
city: Levallois-perret
country: France
facility: Institut Hospitalier Franco-Britannique
city: Lille
country: France
facility: Centre Oscar Lambret
city: Nantes
country: France
facility: CHU Nantes
city: Poitiers
country: France
facility: Chu Poitiers
Study officials:
affiliation: Centre Georges François Leclerc
name: Charles Coutant, PU-PH
role: STUDY_DIRECTOR
References: