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

Cancer Clinical Trial

— EXOMA2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04614480
• Other study ID #: 2019-A02135-52
• Status: Recruiting
• Phase: Phase 2
• Start date: August 25, 2020
• Est. completion date: September 15, 2029

Study information

• Verified date: October 2023
• Source: Centre Georges Francois Leclerc
• Contact: François Ghiringhelli, PU-PH
• Phone: +33(0)3 80 73 75 00
• Email: FGhiringhelli[@]cgfl.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2518
• Est. completion date: September 15, 2029
• Est. primary completion date: September 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Criterion making it possible to definitively validate the inclusion (inclusion in two stages):

12. Samples (tumor + blood) received by the CGFL with sufficient quantity and quality to perform the exoma analysis.

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).

Related Conditions & MeSH terms

• Cancer

Intervention

Genetic:
• Exome analysis
Exome analysis of tumor DNA and constitutional DNA in patients included in 1st line treatment

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens
France	CHRU Jean Minjoz	Besançon
France	Institut Bergonie	Bordeaux
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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Georges Francois Leclerc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients for whom therapy was initiated from informations of the "complex" exome analysis		inclusion