Exome Analysis (Complexe vs Simple) to Help the Therapeutic Decision for the Precision Medicine
NCT ID: NCT04614480
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
7976 participants
INTERVENTIONAL
2020-08-25
2032-09-02
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Metastatic breast cancers
Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Metastatic prostate cancers
Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Metastatic lung cancers
Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Metastatic colorectal cancers
Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
metastatic otorhinolaryngeal cancer
Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
metastatic ovarian cancer
Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Pancreatic cancers
Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Others metastatic cancers
Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Metastatic sarcoma
Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Metastatic gynecological cancer
Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Metastatic renal cancer
Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Metastatic cholangiocarcinoma metastatic
Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Metastatic digestive cancer (other than stomach and colorectal)
Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Metastatic stomach cancer
Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Interventions
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Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
No
Sponsors
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Centre Georges Francois Leclerc
OTHER
Responsible Party
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Principal Investigators
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Charles Coutant, PU-PH
Role: STUDY_DIRECTOR
Centre Georges François Leclerc
Locations
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CHU Amiens Picardie
Amiens, , France
CHRU Jean Minjoz
Besançon, , France
Institut Bergonie
Bordeaux, , France
Centre Henri Baclesse
Caen, , France
CGFL
Dijon, , 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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019-A02135-52
Identifier Type: -
Identifier Source: org_study_id
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