Validation of a microRNA-based Fecal (miRFec) Test for Colorectal Cancer Screening, Surveillance and Diagnosis

NCT05346757 | Recruiting

• 1 other identifier: miRFec001
• Study Type: interventional
• Target: 5,390
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aims to compare effectiveness and cost-effectiveness of the miRFec test with respect to fecal immunochemical test (FIT) for the detection of advanced colorectal neoplasm among individuals participating in colorectal cancer (CRC) screening, surveillance and diagnosis.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Sensitivity for advanced colorectal neoplasm

  To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced colorectal neoplasm

  Through study completion, an average of 3 years

Secondary Outcomes (8)

• Specificity

  Through study completion, an average of 3 years

• Sensitivity for colorectal cancer

  Through study completion, an average of 3 years

• Sensitivity for advanced adenomas

  Through study completion, an average of 3 years

• Sensitivity for advanced serrated lesions

  Through study completion, an average of 3 years

• Detection rate for advanced colorectal neoplasm

  Through study completion, an average of 3 years

Study Arms (1)

miRFec test

OTHER

The miRFec test corresponds to the combination of fecal hemoglobin concentration and fecal miRNA expression

Diagnostic Test: miRFec test

Interventions

miRFec test DIAGNOSTIC_TEST

The miRFec test actually corresponds to the combination of fecal hemoglobin concentration (ie. FIT) and fecal miRNA expression

miRFec test

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 50 to 75 (average-risk) referred to colonoscopy-based CRC screening.
• Male or female aged 30 to 80 with family history of CRC (moderate-risk) referred to colonoscopy-based CRC screening.
• Male and female aged 18 or older with personal history of colorectal polyps referred to colonoscopy surveillance.
• Male and female aged 18 or older with personal history of CRC referred to colonoscopy surveillance.
• Male and female aged 18 or older with colorectal symptoms referred to diagnostic colonoscopy.

You may not qualify if:

• Lack of informed consent to participate
• Personal history of Lynch syndrome
• Personal history of adenomatous or hamartomatous polyposis
• Personal history of serrated polyposis syndrome
• Personal history of inflammatory bowel disease
• Personal history of total colectomy for any reason
• Family history of Lynch syndrome
• Family history of adenomatous or hamartomatous polyposis
• Family history of serrated polyposis syndrome

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead

Study Sites (1)

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

RECRUITING

Related Publications (2)

• Duran-Sanchon S, Moreno L, Auge JM, Serra-Burriel M, Cuatrecasas M, Moreira L, Martin A, Serradesanferm A, Pozo A, Costa R, Lacy A, Pellise M, Lozano JJ, Gironella M, Castells A. Identification and Validation of MicroRNA Profiles in Fecal Samples for Detection of Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):947-957.e4. doi: 10.1053/j.gastro.2019.10.005. Epub 2019 Oct 14.

  PMID: 31622624 BACKGROUND

• Duran-Sanchon S, Moreno L, Gomez-Matas J, Auge JM, Serra-Burriel M, Cuatrecasas M, Moreira L, Serradesanferm A, Pozo A, Grau J, Pellise M, Gironella M, Castells A. Fecal MicroRNA-Based Algorithm Increases Effectiveness of Fecal Immunochemical Test-Based Screening for Colorectal Cancer. Clin Gastroenterol Hepatol. 2021 Feb;19(2):323-330.e1. doi: 10.1016/j.cgh.2020.02.043. Epub 2020 Feb 28.

  PMID: 32113893 RESULT

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

Study Officials

• Antoni Castells, MD, PhD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mireia Diaz

CONTACT

932275703; mdiazc@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Once the participant accepts to participate in the study, a fecal sample collection kit will be delivered together with the sample collection instructions. The sample must be collected at home before starting bowel preparation, more specifically between 24-72 hours before the day that colonoscopy is scheduled. Both miRNA expression and FIT will be analyzed in a central laboratory (Hospital Clinic of Barcelona) from the same fecal sample.

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 26, 2022
• Study Start: March 23, 2022
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of the study
• Access Criteria: Request to the study's principal investigator

Locations

ES (1)