Status:
RECRUITING
Validation of a microRNA-based Fecal (miRFec) Test for Colorectal Cancer Screening, Surveillance and Diagnosis
Lead Sponsor:
Fundacion Clinic per a la Recerca Biomédica
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
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 indivi...
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 effectiv...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
5390 Patients enrolled
Trial Details
Trial ID
NCT05346757
Start Date
March 23 2022
End Date
January 31 2027
Last Update
March 13 2025
Active Locations (1)
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1
Hospital Clinic of Barcelona
Barcelona, Spain, 08036