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Diagnostic Accuracy of a Panel of Bacterial Gene Markers (M3) for Colorectal Advanced Neoplasia

Study acronym: M3-PRO
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 1 of 2 entries Trial status changed: Unknown → Active, Not Recruiting · Primary completion date changed from estimate of Jun 15, 2025 to May 7, 2025 · Completion pushed from Dec 31, 2025 to Dec 31, 2030 · 4 more Show 7 more changesShow less
    • Trial status changed: Unknown → Active, Not Recruiting
    • Primary completion date changed from estimate of Jun 15, 2025 to May 7, 2025
    • Completion pushed from Dec 31, 2025 to Dec 31, 2030
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 5 of 13 entries
    • Site details revised
    • Collaborators: details revised at 1 of 10 entries
  2. Changed Registry marked status Unknown; last known: Recruiting
  3. Trial status: Recruiting to Unknownv4
  4. Primary endpoints revised (2) Secondary endpoints: 8 to 13 · Collaborators expanded, about 39 wordsv3 Show 2 more changesShow less
    • Secondary endpoints: 8 to 13
    • Collaborators expanded, about 39 words

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jun 15, 2022 to Jun 29, 2022v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 15, 2022 to Jun 29, 2022
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 investigators aim to evaluate and compare the diagnostic accuracy of FIT and the novel panel of bacterial gene markers (Fn, m3, Ch and Bc) collectively named as M3, in detecting colorectal advanced neoplasia.
Trial Details
NCT Number NCT05405673
Lead Sponsor Chinese University of Hong Kong
Collaborators: Dr Cipto Mangunkusumo General Hospital, Aster CMI Hospital, Osaka International Cancer Institute, Sano hospital, Thingangyun Sanpya General Hospital, Changi General Hospital, National Taiwan University Hospital, Phramongkutklao College of Medicine and Hospital, St. Mark's Hospital, Oxford University Hospitals NHS Trust
Conditions Colorectal Cancer, Colorectal Neoplasms, Colorectal Adenoma
Enrollment 2,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov