Validation of a microRNA-based Fecal (miRFec) Test for Colorectal Cancer Screening

Colorectal Cancer Clinical Trial

— miRFec  

Official title:

Prospective, Multicenter, Comparative, Parallel Study to Validate a microRNA-based Fecal Test for Colorectal Cancer Screening. The miRFec Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05346757
• Other study ID #: miRFec001
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2022
• Est. completion date: January 31, 2027

Study information

• Verified date: October 2023
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: Mireia Diaz
• Phone: 932275703
• Email: mdiazc[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 programs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9670
• Est. completion date: January 31, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Exclusion Criteria:

• Lack of informed consent to participate
• Personal history of CRC, regardless when it was diagnosed
• Personal history of any other cancer in the last five years, except for non-melanoma skin cancer
• 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clinic of Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Clinic per a la Recerca Biomédica

Country where clinical trial is conducted

Spain, 

References & 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. — View 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 S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Specificity	To compare the specificity of the miRFec test with respect to FIT	Through study completion, an average of 3 years
Secondary	Sensitivity for colorectal cancer	To compare the sensitivity of the miRFec test with respect to FIT for the detection of colorectal cancer	Through study completion, an average of 3 years
Secondary	Sensitivity for advanced adenomas	To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced adenomas	Through study completion, an average of 3 years
Secondary	Sensitivity for advanced serrated lesions	To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced serrated lesions	Through study completion, an average of 3 years
Secondary	Detection rate for advanced colorectal neoplasm	To compare the detection rate for advanced colorectal neoplasm of the miRFec test with respect to FIT	Through study completion, an average of 3 years
Secondary	Discrimination capacity for advanced colorectal neoplasms	To compare the discrimination capacity of the miRFec score and fecal hemoglobin concentration for the detection of advanced colorectal neoplasm	Through study completion, an average of 3 years
Secondary	Discrimination capacity for colorectal cancer	To compare the discrimination capacity of the miRFec score and fecal hemoglobin concentration for the detection of colorectal cancer	Through study completion, an average of 3 years
Secondary	Cost-effectiveness for advanced colorectal neoplasm detection	To compare the cost (euros) for detecting one advanced colorectal neoplasm using the miRFec test with respect to the corresponding figure using FIT	Through study completion, an average of 3 years