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Validation of a microRNA-based Fecal (miRFec) Test for Colorectal Cancer Screening (miRFec)

Primary Purpose

Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
miRFec test
Sponsored by
Fundacion Clinic per a la Recerca Biomédica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Exclusion Criteria:

  • Lack of informed consent to participate
  • Personal history of CRC, regardless when it was diagnosed
  • Personal history of any other cancer in the last five years, except for non-melanoma skin cancer
  • 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

Sites / Locations

  • Hospital Clinic of BarcelonaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

miRFec test

Arm Description

The miRFec test corresponds to the combination of fecal hemoglobin concentration and fecal miRNA expression

Outcomes

Primary Outcome Measures

Sensitivity for advanced colorectal neoplasm
To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced colorectal neoplasm

Secondary Outcome Measures

Specificity
To compare the specificity of the miRFec test with respect to FIT
Sensitivity for colorectal cancer
To compare the sensitivity of the miRFec test with respect to FIT for the detection of colorectal cancer
Sensitivity for advanced adenomas
To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced adenomas
Sensitivity for advanced serrated lesions
To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced serrated lesions
Detection rate for advanced colorectal neoplasm
To compare the detection rate for advanced colorectal neoplasm of the miRFec test with respect to FIT
Discrimination capacity for advanced colorectal neoplasms
To compare the discrimination capacity of the miRFec score and fecal hemoglobin concentration for the detection of advanced colorectal neoplasm
Discrimination capacity for colorectal cancer
To compare the discrimination capacity of the miRFec score and fecal hemoglobin concentration for the detection of colorectal cancer
Cost-effectiveness for advanced colorectal neoplasm detection
To compare the cost (euros) for detecting one advanced colorectal neoplasm using the miRFec test with respect to the corresponding figure using FIT

Full Information

First Posted
April 13, 2022
Last Updated
October 11, 2023
Sponsor
Fundacion Clinic per a la Recerca Biomédica
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1. Study Identification

Unique Protocol Identification Number
NCT05346757
Brief Title
Validation of a microRNA-based Fecal (miRFec) Test for Colorectal Cancer Screening
Acronym
miRFec
Official Title
Prospective, Multicenter, Comparative, Parallel Study to Validate a microRNA-based Fecal Test for Colorectal Cancer Screening. The miRFec Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2022 (Actual)
Primary Completion Date
January 31, 2027 (Anticipated)
Study Completion Date
January 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion Clinic per a la Recerca Biomédica

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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 programs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Once the participant accepts to participate in the study, a fecal sample collection kit will be delivered together with the sample collection instructions. The sample must be collected at home before starting bowel preparation, more specifically between 24-72 hours before the day that colonoscopy is scheduled. Both miRNA expression and FIT will be analyzed in a central laboratory (Hospital Clinic of Barcelona) from the same fecal sample.
Masking
None (Open Label)
Allocation
N/A
Enrollment
9670 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
miRFec test
Arm Type
Other
Arm Description
The miRFec test corresponds to the combination of fecal hemoglobin concentration and fecal miRNA expression
Intervention Type
Diagnostic Test
Intervention Name(s)
miRFec test
Intervention Description
The miRFec test actually corresponds to the combination of fecal hemoglobin concentration (ie. FIT) and fecal miRNA expression
Primary Outcome Measure Information:
Title
Sensitivity for advanced colorectal neoplasm
Description
To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced colorectal neoplasm
Time Frame
Through study completion, an average of 3 years
Secondary Outcome Measure Information:
Title
Specificity
Description
To compare the specificity of the miRFec test with respect to FIT
Time Frame
Through study completion, an average of 3 years
Title
Sensitivity for colorectal cancer
Description
To compare the sensitivity of the miRFec test with respect to FIT for the detection of colorectal cancer
Time Frame
Through study completion, an average of 3 years
Title
Sensitivity for advanced adenomas
Description
To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced adenomas
Time Frame
Through study completion, an average of 3 years
Title
Sensitivity for advanced serrated lesions
Description
To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced serrated lesions
Time Frame
Through study completion, an average of 3 years
Title
Detection rate for advanced colorectal neoplasm
Description
To compare the detection rate for advanced colorectal neoplasm of the miRFec test with respect to FIT
Time Frame
Through study completion, an average of 3 years
Title
Discrimination capacity for advanced colorectal neoplasms
Description
To compare the discrimination capacity of the miRFec score and fecal hemoglobin concentration for the detection of advanced colorectal neoplasm
Time Frame
Through study completion, an average of 3 years
Title
Discrimination capacity for colorectal cancer
Description
To compare the discrimination capacity of the miRFec score and fecal hemoglobin concentration for the detection of colorectal cancer
Time Frame
Through study completion, an average of 3 years
Title
Cost-effectiveness for advanced colorectal neoplasm detection
Description
To compare the cost (euros) for detecting one advanced colorectal neoplasm using the miRFec test with respect to the corresponding figure using FIT
Time Frame
Through study completion, an average of 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 Exclusion Criteria: Lack of informed consent to participate Personal history of CRC, regardless when it was diagnosed Personal history of any other cancer in the last five years, except for non-melanoma skin cancer 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mireia Diaz
Phone
932275703
Email
mdiazc@clinic.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoni Castells, MD, PhD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic of Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mireia Diaz
Phone
+34932275703
Email
mdiazc@clinic.cat

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All individual participant data that underlie results in a publication
IPD Sharing Time Frame
After the end of the study
IPD Sharing Access Criteria
Request to the study's principal investigator
Citations:
PubMed Identifier
31622624
Citation
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.
Results Reference
background
PubMed Identifier
32113893
Citation
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.
Results Reference
result

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Validation of a microRNA-based Fecal (miRFec) Test for Colorectal Cancer Screening

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