Exome Analysis (Complexe vs Simple) to Help the Therapeutic Decision for the Precision Medicine
EXOMA2
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
1 other identifier
interventional
7,976
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 cancer
Started Aug 2020
Longer than P75 for phase_2 cancer
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 25, 2020
CompletedFirst Submitted
Initial submission to the registry
October 29, 2020
CompletedFirst Posted
Study publicly available on registry
November 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 2, 2032
September 22, 2025
September 1, 2025
8 years
October 29, 2020
September 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
proportion of patients for whom therapy was initiated from informations of the "complex" exome analysis
inclusion
Study Arms (14)
Metastatic breast cancers
OTHERMetastatic prostate cancers
OTHERMetastatic lung cancers
OTHERMetastatic colorectal cancers
OTHERmetastatic otorhinolaryngeal cancer
OTHERmetastatic ovarian cancer
OTHERPancreatic cancers
OTHEROthers metastatic cancers
OTHERMetastatic sarcoma
OTHERMetastatic gynecological cancer
OTHERMetastatic renal cancer
OTHERMetastatic cholangiocarcinoma metastatic
OTHERMetastatic digestive cancer (other than stomach and colorectal)
OTHERMetastatic stomach cancer
OTHERInterventions
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Eligibility Criteria
You may qualify if:
- 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
- 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.
You may not qualify if:
- Tumor material not available or biopsy not possible.
- Inability to take a blood test.
- Refusal of genetic analysis.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
CHU Amiens Picardie
Amiens, France
CHRU Jean Minjoz
Besançon, France
Institut Bergonie
Bordeaux, France
Centre Henri Baclesse
Caen, France
CGFL
Dijon, 21079, France
CHU François Mitterrand
Dijon, France
Institut Hospitalier Franco-Britannique
Levallois-Perret, France
Centre Oscar Lambret
Lille, France
CHU Nantes
Nantes, France
Chu Poitiers
Poitiers, France
Institut JeanGodinot
Reims, France
Centre Eugène Marquis
Rennes, France
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Charles Coutant, PU-PH
Centre Georges François Leclerc
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2020
First Posted
November 4, 2020
Study Start
August 25, 2020
Primary Completion (Estimated)
September 2, 2028
Study Completion (Estimated)
September 2, 2032
Last Updated
September 22, 2025
Record last verified: 2025-09