Using advanced genetic analysis to guide cancer treatment decisions

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

This study is testing whether a more detailed genetic analysis can help doctors make better treatment choices for patients with advanced cancer compared to a simpler test.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7976 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Georges Francois Leclerc (Academic / other)
• Locations: 12 sites (Amiens and 11 other locations)
• Trial ID: NCT04614480 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of complex exome analysis compared to simple exome analysis in guiding treatment decisions for patients with metastatic or locally advanced solid tumors. By analyzing structural DNA data, including mutational signatures and tumor mutational load, the study aims to determine how much additional information can influence therapy choices. The goal is to assess the proportion of patients whose treatment is altered based on insights gained from the complex analysis that would not be available through standard methods.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with metastatic or locally advanced solid tumors who are starting their first line of treatment.

Not a fit: Patients without available tumor material or those who refuse genetic analysis may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more personalized and effective treatment options for cancer patients.

How similar studies have performed: While the specific approach of complex exome analysis is novel, similar genetic analysis methods have shown promise in improving treatment decisions in other studies.

Eligibility criteria

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).

Where this trial is running

Amiens and 11 other locations

• CHU Amiens Picardie — Amiens, France (Not_yet_recruiting)
• CHRU Jean Minjoz — Besançon, France (Recruiting)
• Institut Bergonie — Bordeaux, France (Terminated)
• Centre Henri Baclesse — Caen, France (Recruiting)
• Cgfl — Dijon, France (Recruiting)
• CHU François Mitterrand — Dijon, France (Recruiting)
• Institut Hospitalier Franco-Britannique — Levallois-Perret, France (Terminated)
• Centre Oscar Lambret — Lille, France (Recruiting)
• CHU Nantes — Nantes, France (Terminated)
• Chu Poitiers — Poitiers, France (Terminated)
• Institut JeanGodinot — Reims, France (Recruiting)
• Centre Eugène Marquis — Rennes, France (Recruiting)

Study contacts

• Study coordinator: François Ghiringhelli, PU-PH

Conditions Cancer; genetic; exome