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Prognostic Role of Circulating Tumor DNA in Resectable Pancreatic Cancer

Study acronym: PROJECTION
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 11, 2025 (before its estimated December 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Dec 1, 2024 to Dec 1, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 1, 2025 to Dec 1, 2026
    • Site details revised at 6 of 6 sites
    v6
  2. Primary completion date: Mar 1, 2024 to Dec 1, 2024
    • Study completion date: Mar 1, 2025 to Dec 1, 2025
    v5
  3. Primary completion date: Mar 1, 2022 to Mar 1, 2024
    • Start date: Dec 1, 2020 to Dec 12, 2021
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 5 to 6
    • Start date changed from estimate of Jan 1, 2021 to Dec 1, 2020
    v3
  5. Start date: Mar 1, 2020 to Jan 1, 2021v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a non-randomized, multicenter, non-interventional study in patients with resectable PDAC. The patients are allocated to two observation groups according preoperative presence of ctDNA (Group A) or absence of detectable ctDNA (Group B) as determined in a liquid biopsy. After successful surgery of their pancreatic tumor and completion of local histological evaluation, tissue samples will be analyzed with regard to their mutational status with. Within 14 days before start of adjuvant tumor therapy another liquid biopsy will be taken to reassess the level of ctDNA after surgery. Patients will be monitored for disease recurrence according to harmonized, institutional standards using clinical, laboratory and (cross-sectional) imaging modalities. Accordingly, patients will be assessed every three months in the first eighteen months after surgery and every six months thereafter or based on clinical need for 36 months after the date of surgery Follow up will be documented until occurrence of relapse (or death if death occurs earlier than relapse/progression) for a maximum of 36 months after the date of surgery.
Trial Details
NCT Number NCT04246203
Lead Sponsor Ludwig-Maximilians - University of Munich
Collaborators: Hoffmann-La Roche
Conditions
(from sponsor)		 Pancreas Cancer
Related terms Pancreatic Neoplasms
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov