NCT05346757 Validation of a microRNA-based Fecal (miRFec) Test for Colorectal Cancer Screening, Surveillance and Diagnosis
| NCT ID | NCT05346757 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundacion Clinic per a la Recerca Biomédica |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 5,390 participants |
| Start Date | 2022-03-23 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5,390 participants in total. It began in 2022-03-23 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Antoni Castells, MD, PhD
PRINCIPAL INVESTIGATOR
Hospital Clinic of Barcelona
Frequently Asked Questions
Who can join the NCT05346757 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05346757 currently recruiting?
Yes, NCT05346757 is actively recruiting participants. Contact the research team at mdiazc@clinic.cat for enrollment information.
Where is the NCT05346757 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT05346757 clinical trial?
NCT05346757 is sponsored by Fundacion Clinic per a la Recerca Biomédica. The principal investigator is Antoni Castells, MD, PhD at Hospital Clinic of Barcelona. The trial plans to enroll 5,390 participants.
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