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Recruiting NCT05346757

Validation of a microRNA-based Fecal (miRFec) Test for Colorectal Cancer Screening, Surveillance and Diagnosis

No phase Interventional Colorectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: miRFec test.
Who it may be relevant to
Registry conditions: Colorectal Cancer. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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 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 and surveillance programs, and diagnosis.

Interventions

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

Primary outcome measures

  • Sensitivity for advanced colorectal neoplasm [Time frame: Through study completion, an average of 3 years]
Secondary outcome measures (8)
  • Specificity [Time frame: Through study completion, an average of 3 years]
  • Sensitivity for colorectal cancer [Time frame: Through study completion, an average of 3 years]
  • Sensitivity for advanced adenomas [Time frame: Through study completion, an average of 3 years]
  • Sensitivity for advanced serrated lesions [Time frame: Through study completion, an average of 3 years]
  • Detection rate for advanced colorectal neoplasm [Time frame: Through study completion, an average of 3 years]
  • Discrimination capacity for advanced colorectal neoplasms [Time frame: Through study completion, an average of 3 years]
  • Discrimination capacity for colorectal cancer [Time frame: Through study completion, an average of 3 years]
  • Cost-effectiveness for advanced colorectal neoplasm detection [Time frame: Through study completion, an average of 3 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

Spain · 1 center
  • Hospital Clinic of Barcelona — Barcelona

Publications

  • 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. PMID 31622624
  • 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. PMID 32113893

Identifiers

NCT: NCT05346757 · miRFec001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗