Exome Analysis (Complexe vs Simple) to Help the Therapeutic Decision for the Precision Medicine

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cancer

Intervention / Treatment
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* Genetic: Exome analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) 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. Criterion making it possible to definitively validate the inclusion (inclusion in two stages): Samples (tumor + blood) received by the CGFL with sufficient quantity and quality to perform the exoma analysis. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Metastatic breast cancers<br> | Genetic: Exome analysis<br>* Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment<br>|
| Other: Metastatic prostate cancers<br> | Genetic: Exome analysis<br>* Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment<br>|
| Other: Metastatic lung cancers<br> | Genetic: Exome analysis<br>* Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment<br>|
| Other: Metastatic colorectal cancers<br> | Genetic: Exome analysis<br>* Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment<br>|
| Other: metastatic otorhinolaryngeal cancer<br> | Genetic: Exome analysis<br>* Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment<br>|
| Other: metastatic ovarian cancer<br> | Genetic: Exome analysis<br>* Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment<br>|
| Other: Pancreatic cancers<br> | Genetic: Exome analysis<br>* Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment<br>|
| Other: Others metastatic cancers<br> | Genetic: Exome analysis<br>* Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment<br>|
| Other: Metastatic sarcoma<br> | Genetic: Exome analysis<br>* Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients for whom therapy was initiated from informations of the complex exome analysis |  | inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genetic, exome