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

Prioritizing Resumption of Colorectal Screening After COVID

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06607614
Acronym
PRIORITIZE
Enrollment
10000
Registered
2024-09-23
Start date
2024-11-01
Completion date
2026-08-01
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer Screening

Keywords

fecal immunochemical test, Colorectal cancer, screening program

Brief summary

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.

Interventions

OTHERColorectal Cancer Screening Fecal Immunochemical Test

Fecal Immunochemical Test

Sponsors

European Society of Gastrointestinal Endoscopy
CollaboratorOTHER
Catholic University of the Sacred Heart
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Colorectal cancer rate in the different risk groups12 monthsColorectal cancer rate in the different risk groups

Secondary

MeasureTime frameDescription
Advanced adenoma rate in the different risk group12 monthsAdvanced adenoma rate in the different risk group
Any adenoma rate in the different risk groups12 monthsAny adenoma rate in the different risk groups

Contacts

Primary ContactPecere Silvia M.D. PhD
silvia.pecere@policlinicogemelli.it0630156580

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026