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

Study acronym: EXOMA2
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 2518 to 7976 Primary completion date: Sep 15, 2025 to Sep 2, 2028 · Study sites: 9 to 12 · Completion date: Sep 15, 2029 to Sep 2, 2032v8 Show 3 more changesShow less
    • Primary completion date: Sep 15, 2025 to Sep 2, 2028
    • Study sites: 9 to 12
    • Completion date: Sep 15, 2029 to Sep 2, 2032
  2. Eligibility criteria shortened, about 31 words Study arms: 9 to 14v7 Show 1 more changeShow less
    • Study arms: 9 to 14

    See this version in full on ClinicalTrials.gov ↗

  3. Enrollment target: 2018 to 2518v6
  4. Re-verified, no change to tracked fieldsv5
  5. Enrollment target: 1644 to 2018 Eligibility criteria shortened, about 12 words · Study arms: 8 to 9v4 Show 2 more changesShow less
    • Eligibility criteria shortened, about 12 words
    • Study arms: 8 to 9

    See this version in full on ClinicalTrials.gov ↗

Show 2 earlier versionsHide 2 earlier versions
  1. Phase: Not specified to Phase 2 Enrollment target: 1392 to 1644 · Start date: Sep 15, 2020 to Aug 25, 2020v3 Show 2 more changesShow less
    • Enrollment target: 1392 to 1644
    • Start date: Sep 15, 2020 to Aug 25, 2020
  2. Primary completion date: Sep 2, 2024 to Sep 15, 2025 Completion date: Mar 2, 2025 to Sep 15, 2029 · Start date: Sep 2, 2020 to Sep 15, 2020v2 Show 2 more changesShow less
    • Completion date: Mar 2, 2025 to Sep 15, 2029
    • Start date: Sep 2, 2020 to Sep 15, 2020
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04614480
Lead Sponsor Centre Georges Francois Leclerc
Conditions Cancer
Enrollment 7,976 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov