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

NCT06607614 | Not Yet Recruiting

• 1 other identifier: 6404
• Study Type: observational
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer Screening

Keywords

fecal immunochemical test; Colorectal cancer; screening program

Outcome Measures

Primary Outcomes (1)

• Colorectal cancer rate in the different risk groups

  Colorectal cancer rate in the different risk groups

  12 months

Secondary Outcomes (2)

• Advanced adenoma rate in the different risk group

  12 months

• Any adenoma rate in the different risk groups

  12 months

Study Arms (1)

Prospective cohort

All FIT+ patients of participating centers that are active in the CRC regional screening programs, with follow up colonscopies scheduled according to the developed scoring system.

Other: Colorectal Cancer Screening Fecal Immunochemical Test

Interventions

Colorectal Cancer Screening Fecal Immunochemical Test OTHER

Fecal Immunochemical Test

Also known as: Fecal Immunochemical Test

Prospective cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with FIT+, scheduled for colonoscopy

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead
• European Society of Gastrointestinal Endoscopy: collaborator

Related Publications (4)

• Cubiella J, Digby J, Rodriguez-Alonso L, Vega P, Salve M, Diaz-Ondina M, Strachan JA, Mowat C, McDonald PJ, Carey FA, Godber IM, Younes HB, Rodriguez-Moranta F, Quintero E, Alvarez-Sanchez V, Fernandez-Banares F, Boadas J, Campo R, Bujanda L, Garayoa A, Ferrandez A, Pinol V, Rodriguez-Alcalde D, Guardiola J, Steele RJ, Fraser CG; COLONPREDICT study investigators. The fecal hemoglobin concentration, age and sex test score: Development and external validation of a simple prediction tool for colorectal cancer detection in symptomatic patients. Int J Cancer. 2017 May 15;140(10):2201-2211. doi: 10.1002/ijc.30639. Epub 2017 Mar 6.

  PMID: 28187494 BACKGROUND

• Park CH, Jung YS, Kim NH, Park JH, Park DI, Sohn CI. Usefulness of risk stratification models for colorectal cancer based on fecal hemoglobin concentration and clinical risk factors. Gastrointest Endosc. 2019 Jun;89(6):1204-1211.e1. doi: 10.1016/j.gie.2019.02.023. Epub 2019 Feb 25.

  PMID: 30817918 BACKGROUND

• Kim NH, Lim JW, Kim S, Lim JY, Kim W, Park JH, Park DI, Sohn CI, Jung YS. Association of time to colonoscopy after a positive fecal test result and fecal hemoglobin concentration with risk of advanced colorectal neoplasia. Dig Liver Dis. 2019 Apr;51(4):589-594. doi: 10.1016/j.dld.2018.12.008. Epub 2018 Dec 23.

  PMID: 30733186 BACKGROUND

• Zorzi M, Hassan C, Capodaglio G, Baracco M, Antonelli G, Bovo E, Rugge M. Colonoscopy later than 270 days in a fecal immunochemical test-based population screening program is associated with higher prevalence of colorectal cancer. Endoscopy. 2020 Oct;52(10):871-876. doi: 10.1055/a-1159-0644. Epub 2020 Apr 30.

  PMID: 32356282 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Pecere Silvia M.D. PhD

CONTACT

0630156580; silvia.pecere@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. PhD

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: November 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 23, 2024

Record last verified: 2024-09