Validation of a microRNA-based Fecal (miRFec) Test for Colorectal Cancer Screening, Surveillance and Diagnosis
NCT ID: NCT05346757
Last Updated: 2025-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
5390 participants
INTERVENTIONAL
2022-03-23
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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miRFec test
The miRFec test corresponds to the combination of fecal hemoglobin concentration and fecal miRNA expression
miRFec test
The miRFec test actually corresponds to the combination of fecal hemoglobin concentration (ie. FIT) and fecal miRNA expression
Interventions
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miRFec test
The miRFec test actually corresponds to the combination of fecal hemoglobin concentration (ie. FIT) and fecal miRNA expression
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Fundacion Clinic per a la Recerca Biomédica
OTHER
Responsible Party
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Antoni Castells
Principal investigator
Principal Investigators
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Antoni Castells, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Locations
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Hospital Clinic of Barcelona
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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miRFec001
Identifier Type: -
Identifier Source: org_study_id
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