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Longitudinal Multimodal Response Assessment During Neoadjuvant Treatment of Rectal Cancer

Study acronym: PRIMO
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv9
  2. Notable Primary completion date: Dec 31, 2024 to Jan 31, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v8
  3. Minor Enrollment target: 50 to 40v7
  4. Minor Eligibility criteria shortened, about 1 wordv6
  5. Minor Study description expanded, about 1 wordv5
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  1. Minor Secondary endpoints: 6 to 7v4
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Secondary endpoints: 5 to 6
    v3
  3. Notable Start date: Oct 1, 2022 to Nov 30, 2022
    • Eligibility criteria shortened, about 11 words
    • Study description expanded, about 28 words
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 pilot study aims to trial multimodal early response assessment to enable therapy adaptions in the context of non-operative therapy strategies of locally advanced rectal cancer (LARC) for development of a non-invasive response prediction model.
Trial Details
NCT Number NCT05524012
Lead Sponsor Jena University Hospital
Conditions
(from sponsor)
Locally Advanced Rectal Carcinoma, Neoadjuvant Treatment, Radiotherapy, Adaptive Treatment
Related terms Neoplastic Cells, Circulating, Rectal Neoplasms
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov