Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06607614

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All FIT+ patients awaiting to be scheduled for colonoscopy workup. Patients will be invited to undergo a colonoscopy, and depending on its outcome, patients are referred for surgery, postcolonoscopy surveillance, or further rounds of FIT.

Exclusion criteria

  • Individuals with a prevalent diagnosis of CRC are excluded from the program, as well as patients that have already undergone a high quality colonoscopy.

Treatment and study plan

Colorectal Cancer Screening Fecal Immunochemical Test

Other

Fecal Immunochemical Test

Other names: Fecal Immunochemical Test

Primary outcomes

  1. Colorectal cancer rate in the different risk groups

    Time frame: 12 months

    Colorectal cancer rate in the different risk groups

Secondary outcomes

  1. Advanced adenoma rate in the different risk group

    Time frame: 12 months

    Advanced adenoma rate in the different risk group

  2. Any adenoma rate in the different risk groups

    Time frame: 12 months

    Any adenoma rate in the different risk groups

Study contacts

Contact information is provided by the study sponsor or research team.

Pecere Silvia M.D. PhD

CONTACT

[email protected]

0630156580 ext. +39

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Collaborators

  • European Society of Gastrointestinal Endoscopy

Registry information

Official study title

Prioritizing Resumption of Colorectal Screening After COVID

Acronym: PRIORITIZE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.