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A Predictive Model Based on Quantitative Fecal Immunochemical Test Can Stratify the Risk of CRC in an Organized Screening Program

Study acronym: PRIORITIZE
StatusUnknown
PhaseNot specified
Started
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Record status
This record was last updated September 23, 2024 (before its estimated May 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Not Yet Recruiting
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The COVID-19 pandemic has disrupted every aspect of medical care, including screening programs and preventive medical care . Organized FIT-based colorectal cancer screening programs make no exception, since their efficacy depends on a multi-tiered series of interventions that were hampered by the pandemic at multiple levels. In detail, the first level of intervention, namely population based FIT tests distributed to the population, has seen a dramatic decrease of number of tests performed for both organizational reasons (i.e. less personnel deployed to testing sites) and for failure to present fecal samples from patients for fear of contagion or impossibility to reach the drop-off sites for state-imposed limitations. Secondly, the referral of FIT positive patients to subsequent colonoscopy was stopped or delayed since endoscopy services have been undergoing only emergent and urgent procedures. Thirdly, patients diagnosed with advanced neoplasia or cancer have seen their endoscopic or surgical removal procedures delayed or canceled . Regarding post-FIT colonoscopy workup, European Screening Guidelines recommend a 30-day maximum span between a positive FIT test and subsequent colonoscopy. It is well known that any delay in post-FIT+ colonoscopy results in an increase in advanced neoplasia and colorectal cancer, that reaches dramatic levels after 6 months . Our purpose is to develop and validate, using the quantitative level of faecal hemoglobin found in FIT, a simple scoring system to effectively sub-stratify CRC risk of FIT positive patients.
Trial Details
NCT Number NCT06607614
Lead Sponsor Catholic University of the Sacred Heart
Collaborators: European Society of Gastrointestinal Endoscopy
Conditions
(from sponsor)
Colorectal Cancer Screening
Related terms Colorectal Neoplasms
Enrollment 10,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov