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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metastatic breast cancers | Other |
| |
| Metastatic prostate cancers | Other |
| |
| Metastatic lung cancers | Other |
| |
| Metastatic colorectal cancers | Other |
| |
| metastatic otorhinolaryngeal cancer | Other |
| |
| metastatic ovarian cancer | Other |
| |
| Pancreatic cancers | Other |
| |
| Others metastatic cancers |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exome analysis | Genetic | Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients for whom therapy was initiated from informations of the "complex" exome analysis | inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| François Ghiringhelli, PU-PH | Contact | +33(0)3 80 73 75 00 | FGhiringhelli@cgfl.fr | |
| Emilie Rederstorff, PhD | Contact | +33(0)3 80 73 75 00 | 34 61 | ERederstorff@cgfl.fr |
| Name | Affiliation | Role |
|---|---|---|
| Charles Coutant, PU-PH | Centre Georges François Leclerc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens Picardie | Not yet recruiting | Amiens | France |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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|
| Metastatic sarcoma | Other |
|
| Metastatic gynecological cancer | Other |
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| Metastatic renal cancer | Other |
|
| Metastatic cholangiocarcinoma metastatic | Other |
|
| Metastatic digestive cancer (other than stomach and colorectal) | Other |
|
| Metastatic stomach cancer | Other |
|
| CHRU Jean Minjoz | Recruiting | Besançon | France |
|
| Institut Bergonie | Terminated | Bordeaux | France |
| Centre Henri Baclesse | Recruiting | Caen | France |
|
| CGFL | Recruiting | Dijon | 21079 | France |
|
| CHU François Mitterrand | Recruiting | Dijon | France |
|
| Institut Hospitalier Franco-Britannique | Terminated | Levallois-Perret | France |
| Centre Oscar Lambret | Recruiting | Lille | France |
|
| CHU Nantes | Terminated | Nantes | France |
| Chu Poitiers | Terminated | Poitiers | France |
| Institut JeanGodinot | Recruiting | Reims | France |
|
| Centre Eugène Marquis | Recruiting | Rennes | France |
|