CancerPhase 2EXOMA2NCT04614480
Exome Analysis (Complexe vs Simple) to Help the Therapeutic Decision for the Precision Medicine
A Phase 2 study testing Exome analysis in people with Cancer, run by Centre Georges Francois Leclerc at 12 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Exome analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,976 participants
- Where
- 12 sitesFrance
- Study dates
- 25 Aug 2020to 2 Sep 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
France12 sites, 8 recruiting
- Not yet recruiting
CHU Amiens Picardie
Amiens
Bruno CHAUFFERT, MD, 03 22 45 54 99, chauffert.bruno@chu-amiens.fr
- Recruiting
CHRU Jean Minjoz
Besançon
Laura MANSI, MD, 03 70 63 24 03, mansi.laura@gmail.com
- Terminated
Institut Bergonie
Bordeaux
- Recruiting
Centre Henri Baclesse
Caen
Hubert CURCIO, Dr, 0231455002, h.curcio@baclesse.unicancer.fr
- Recruiting
CGFL
Dijon, 21079
Emilie Rederstorff, PhD, +33(0)3 80 73 75 00 ext. 34 61, ERederstorff@cgfl.fr
- Recruiting
CHU François Mitterrand
Dijon
Antoine DROUILLARD, MD, 03 80 29 37 50, antoine.drouillard@chu-dijon.fr
- Terminated
Institut Hospitalier Franco-Britannique
Levallois-Perret
- Recruiting
Centre Oscar Lambret
Lille
Nicolas PENEL, MD, 03 20 29 59 59, n-penel@o-lambret.fr
- Terminated
CHU Nantes
Nantes
- Terminated
Chu Poitiers
Poitiers
- Recruiting
Institut JeanGodinot
Reims
Stéphane VIGNOT, Dr, 0326504390, stephane.vigstephane.vignot@reims.unicancer.frnot@reims.unicancer.fr
- Recruiting
Centre Eugène Marquis
Rennes
Antoine DELEUZE, Dr, 0299253000, a.deleuze@rennes.unicancer.fr
About this study
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
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
- Cancer
- Being tested
- Exome analysis
- Keywords
- genetic, exome
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exome analysisGenetic
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
| Study group | Role | What they receive |
|---|---|---|
| Metastatic breast cancers | Other | Not described Receives: Genetic: Exome analysis |
| Metastatic prostate cancers | Other | Not described Receives: Genetic: Exome analysis |
| Metastatic lung cancers | Other | Not described Receives: Genetic: Exome analysis |
| Metastatic colorectal cancers | Other | Not described Receives: Genetic: Exome analysis |
| metastatic otorhinolaryngeal cancer | Other | Not described Receives: Genetic: Exome analysis |
| metastatic ovarian cancer | Other | Not described Receives: Genetic: Exome analysis |
| Pancreatic cancers | Other | Not described Receives: Genetic: Exome analysis |
| Others metastatic cancers | Other | Not described Receives: Genetic: Exome analysis |
| Metastatic sarcoma | Other | Not described Receives: Genetic: Exome analysis |
| Metastatic gynecological cancer | Other | Not described Receives: Genetic: Exome analysis |
| Metastatic renal cancer | Other | Not described Receives: Genetic: Exome analysis |
| Metastatic cholangiocarcinoma metastatic | Other | Not described Receives: Genetic: Exome analysis |
| Metastatic digestive cancer (other than stomach and colorectal) | Other | Not described Receives: Genetic: Exome analysis |
| Metastatic stomach cancer | Other | Not described Receives: Genetic: Exome analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients for whom therapy was initiated from informations of the "complex" exome analysis
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start25 Aug 2020
- Primary completion2 Sep 2028 (estimated)
- Study completion2 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,976 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Coutant, PU-PH, Study director, Centre Georges François Leclerc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614480
- Sponsor's protocol ID
- 2019-A02135-52
- Acronym
- EXOMA2
- Status last verified
- Sep 2025
- First submitted
- 29 Oct 2020
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04614480
- Acronym / sponsor ID
- EXOMA2 / 2019-A02135-52
- Conditions
- Cancer
- Keywords
- genetic, exome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7,976 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 2 Sep 2028 (estimated)
- Study completion
- 2 Sep 2032 (estimated)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Metastatic breast cancers | Other | Genetic: Exome analysis |
| Metastatic prostate cancers | Other | Genetic: Exome analysis |
| Metastatic lung cancers | Other | Genetic: Exome analysis |
| Metastatic colorectal cancers | Other | Genetic: Exome analysis |
| metastatic otorhinolaryngeal cancer | Other | Genetic: Exome analysis |
| metastatic ovarian cancer | Other | Genetic: Exome analysis |
| Pancreatic cancers | Other | Genetic: Exome analysis |
| Others metastatic cancers | Other | Genetic: Exome analysis |
| Metastatic sarcoma | Other | Genetic: Exome analysis |
| Metastatic gynecological cancer | Other | Genetic: Exome analysis |
| Metastatic renal cancer | Other | Genetic: Exome analysis |
| Metastatic cholangiocarcinoma metastatic | Other | Genetic: Exome analysis |
| Metastatic digestive cancer (other than stomach and colorectal) | Other | Genetic: Exome analysis |
| Metastatic stomach cancer | Other | Genetic: Exome analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exome analysisExome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment | Genetic | Metastatic breast cancers, Metastatic cholangiocarcinoma metastatic, Metastatic colorectal cancers, Metastatic digestive cancer (other than stomach and colorectal), Metastatic gynecological cancer, Metastatic lung cancers, Metastatic prostate cancers, Metastatic renal cancer, Metastatic sarcoma, Metastatic stomach cancer, Others metastatic cancers, Pancreatic cancers, metastatic otorhinolaryngeal cancer, metastatic ovarian cancer |
Primary outcome
proportion of patients for whom therapy was initiated from informations of the "complex" exome analysis
Time frame: inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles Coutant, PU-PH study director
Centre Georges François Leclerc
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exome analysis in people with Cancer, run by Centre Georges Francois Leclerc at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact François Ghiringhelli, PU-PH (+33(0)3 80 73 75 00, FGhiringhelli@cgfl.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients for whom therapy was initiated from informations of the "complex" exome analysis (time frame: inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.