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Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study

Study acronym: COPE
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Dec 1, 2026 → May 24, 2027
See other at-risk trials from Institut Bergonié

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Primary completion pushed from Dec 1, 2026 to May 24, 2027
    • Site details revised at 6 of 6 sites
    v7
  2. Primary completion date: Sep 1, 2024 to Dec 1, 2026
    • Study completion date: Apr 1, 2025 to Dec 1, 2027
    v6
  3. Primary completion date: Sep 1, 2023 to Sep 1, 2024
    • Study completion date: Apr 1, 2024 to Apr 1, 2025
    • Eligibility criteria shortened, about 12 words
    • Site details revised at 1 of 6 sites
    v5
  4. Study sites: 1 to 6v4
  5. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Aug 1, 2023 to Sep 1, 2023
    • Study completion date: Mar 1, 2024 to Apr 1, 2024
    • Start date changed from estimate of Aug 1, 2020 to Sep 4, 2020
    • Site details revised
  6. Start date: Mar 1, 2020 to Aug 1, 2020
    • Primary completion date: Mar 1, 2023 to Aug 1, 2023
    • Study completion date: Sep 1, 2023 to Mar 1, 2024
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
COPE is a biology driven protocol with 2 independent, multicentric, two-arm non-comparative randomized (2:1) phase II trials in 2 distinct populations: colorectal cancer patients and non-small-lung cancer patients. For each phase II trial, patient will be randomized between two arms with two patients randomized in arm A for one patient randomized in arm B: * Arm A (Experimental - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up combining standard imaging and ctDNA analysis) * Arm B (Standard - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up based on standard imaging).
Trial Details
NCT Number NCT04258137
Lead Sponsor Institut Bergonié
Conditions
(from sponsor)		 Colorectal Cancer, Non Small Cell Lung Cancer
Related terms Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Neoplasm Metastasis
Enrollment 332 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov