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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCatholic University of the Sacred Heart

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Patients with FIT+, scheduled for colonoscopy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Colorectal Cancer Screening Fecal Immunochemical Test

    Other intervention

    Fecal Immunochemical Test

Treatment groups

10,000 Participants
are divided into 1 treatment group
Group A: Prospective cohort1 intervention

Trial outcomes

Primary outcomes

1

Colorectal cancer rate in the different risk groups

Colorectal cancer rate in the different risk groups

Time frame
12 months

Secondary outcomes

1

Advanced adenoma rate in the different risk group

Advanced adenoma rate in the different risk group

Time frame
12 months
2

Any adenoma rate in the different risk groups

Any adenoma rate in the different risk groups

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Catholic University of the Sacred Heart

Lead sponsor

European Society of Gastrointestinal Endoscopy

Collaborator

This trial is not recruiting at the moment. You can still explore other options: