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

NCT04614480 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7976

Last updated 2025-09-22

No results posted yet for this study

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.

Conditions

Interventions

GENETIC

Exome analysis

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

Sponsors & Collaborators

  • Centre Georges Francois Leclerc

    lead OTHER

Principal Investigators

  • Charles Coutant, PU-PH · Centre Georges François Leclerc

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-25
Primary Completion
2028-09-02
Completion
2032-09-02

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04614480 on ClinicalTrials.gov