Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 2
Centre Georges Francois Leclerc (Voir sur ClinicalTrials)
août 2020
septembre 2032
02 octobre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Antoine ITALIANO | 15/07/2026 15:05:05 | Contacter | ||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Eugène Marquis - Rennes 2983990 - France | Antoine DELEUZE, Dr | Contact (sur clinicalTrials) | |||
| CHRU Jean Minjoz - Besançon 3033123 - France | Laura MANSI, MD | Contact (sur clinicalTrials) | |||
| CHU Amiens Picardie - Amiens 3037854 - France | Bruno CHAUFFERT, MD | Contact (sur clinicalTrials) | |||
| Chu Poitiers - Poitiers 2986495 - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Henri Baclesse - Caen 3029241 - France | Hubert CURCIO, Dr | Contact (sur clinicalTrials) | |||
| Centre Oscar Lambret - Lille 2998324 - France | Nicolas PENEL, MD | Contact (sur clinicalTrials) | |||
| CGFL - 21079 - Dijon 3021372 - France | Emilie Rederstorff, PhD | Contact (sur clinicalTrials) | |||
| CHU François Mitterrand - Dijon 3021372 - France | Antoine DROUILLARD, MD | Contact (sur clinicalTrials) | |||
| CHU Nantes - Nantes 2990969 - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonie - Bordeaux 3031582 - France | Contact (sur clinicalTrials) | ||||
| Institut JeanGodinot - Reims 2984114 - France | Stéphane VIGNOT, Dr | Contact (sur clinicalTrials) | |||
Critères
Tous
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).