Using advanced genetic analysis to guide cancer treatment decisions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHRU Jean Minjoz
  Besançon, France Recruiting
• Centre Henri Baclesse
  Caen, France Recruiting
• Cgfl
  Dijon, France Recruiting
• CHU François Mitterrand
  Dijon, France Recruiting
• Centre Oscar Lambret
  Lille, France Recruiting
• Institut JeanGodinot
  Reims, France Recruiting

Study contacts

• Study coordinator: François Ghiringhelli, PU-PH
• Email: FGhiringhelli@cgfl.fr
• Phone: +33(0)3 80 73 75 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.