Exome Analysis (Complexe vs Simple) to Help the Therapeutic Decision for the Precision Medicine (EXOMA2)

Centre Georges Francois Leclerc

Status and phase: Enrolling; Phase 2

Conditions: Cancer

Treatments: Genetic: Exome analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT04614480

2019-A02135-52

Details and patient eligibility

About

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.

Enrollment: 7,976 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years old
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

1. Tumor material not available or biopsy not possible.
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).

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7,976 participants in 14 patient groups

Metastatic breast cancers

Other group

Treatment:

Genetic: Exome analysis

Metastatic prostate cancers

Other group

Treatment:

Genetic: Exome analysis

Metastatic lung cancers

Other group

Treatment:

Genetic: Exome analysis

Metastatic colorectal cancers

Other group

Treatment:

Genetic: Exome analysis

metastatic otorhinolaryngeal cancer

Other group

Treatment:

Genetic: Exome analysis

metastatic ovarian cancer

Other group

Treatment:

Genetic: Exome analysis

Pancreatic cancers

Other group

Treatment:

Genetic: Exome analysis

Others metastatic cancers

Other group

Treatment:

Genetic: Exome analysis

Metastatic sarcoma

Other group

Treatment:

Genetic: Exome analysis

Metastatic gynecological cancer

Other group

Treatment:

Genetic: Exome analysis

Metastatic renal cancer

Other group

Treatment:

Genetic: Exome analysis

Metastatic cholangiocarcinoma metastatic

Other group

Treatment:

Genetic: Exome analysis

Metastatic digestive cancer (other than stomach and colorectal)

Other group

Treatment:

Genetic: Exome analysis

Metastatic stomach cancer

Other group

Treatment:

Genetic: Exome analysis