Clinical trial NCT05346757: Validation of a microRNA-based Fecal (miRFec) Test for Colorectal Cancer Screening, Surveillance and Diagnosis
Official title: Prospective, Multicenter, Comparative, Paired Study to Validate a microRNA-based Fecal Test for Colorectal Cancer Screening. The miRFec Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 5390
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SCREENING

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.

Detailed description: The miRFec test -a Gradient Boosting Machine-generated algorithm that includes two fecal miRNAs (miR-421 and miR-27a-3p) and fecal hemoglobin concentration, along with age and gender- is more effective and cost-effective than FIT for the identification of patients with advanced colorectal neoplasm (i.e. colorectal cancer, advanced adenomas or advanced serrated lesions) among individuals participating in colorectal cancer screening and surveillance programs, and diagnosis.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Sensitivity for advanced colorectal neoplasm
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
measure: Specificity
timeFrame: Through study completion, an average of 3 years
measure: Sensitivity for colorectal cancer
timeFrame: Through study completion, an average of 3 years
measure: Sensitivity for advanced adenomas
timeFrame: Through study completion, an average of 3 years
measure: Sensitivity for advanced serrated lesions
timeFrame: Through study completion, an average of 3 years
measure: Detection rate for advanced colorectal neoplasm
timeFrame: Through study completion, an average of 3 years
measure: Discrimination capacity for advanced colorectal neoplasms
timeFrame: Through study completion, an average of 3 years
measure: Discrimination capacity for colorectal cancer
timeFrame: Through study completion, an average of 3 years
measure: Cost-effectiveness for advanced colorectal neoplasm detection
timeFrame: Through study completion, an average of 3 years
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Antoni Castells, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.