Validation of a microRNA-based Fecal (miRFec) Test for Colorectal Cancer Screening, Surveillance and Diagnosis
Recruiting · NCT05346757 · Interventional (participants receive a specific treatment) · Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
View the official record on ClinicalTrials.gov →Interventions studied
miRFec test
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Hospital Clinic of Barcelona - Barcelona, Spain