Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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