Colorectal CancermiRFecNCT05346757
Validation of a microRNA-based Fecal (miRFec) Test for Colorectal Cancer Screening, Surveillance and Diagnosis
A study testing miRFec test in people with Colorectal Cancer, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- miRFec test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,390 participants
- Where
- 1 siteSpain
- Study dates
- 23 Mar 2022to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Family history of Lynch syndrome
- Family history of adenomatous or hamartomatous polyposis
- Family history of serrated polyposis syndrome
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic of Barcelona
Barcelona, 08036
Mireia Diaz, +34932275703, mdiazc@clinic.cat
About this study
Official title: Prospective, Multicenter, Comparative, Paired Study to Validate a microRNA-based Fecal Test for Colorectal Cancer Screening. The miRFec Study
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- miRFec test
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miRFec testDiagnostic test
The miRFec test actually corresponds to the combination of fecal hemoglobin concentration (ie. FIT) and fecal miRNA expression
| Study group | Role | What they receive |
|---|---|---|
| miRFec test | Other | The miRFec test corresponds to the combination of fecal hemoglobin concentration and fecal miRNA expression Receives: Diagnostic Test: miRFec test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity for advanced colorectal neoplasm
To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced colorectal neoplasm
Measured: Through study completion, an average of 3 years
Secondary outcomes (8)
Specificity
To compare the specificity of the miRFec test with respect to FIT
Measured: Through study completion, an average of 3 years
Sensitivity for colorectal cancer
To compare the sensitivity of the miRFec test with respect to FIT for the detection of colorectal cancer
Measured: Through study completion, an average of 3 years
Sensitivity for advanced adenomas
To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced adenomas
Measured: Through study completion, an average of 3 years
Sensitivity for advanced serrated lesions
To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced serrated lesions
Measured: Through study completion, an average of 3 years
Detection rate for advanced colorectal neoplasm
To compare the detection rate for advanced colorectal neoplasm of the miRFec test with respect to FIT
Measured: Through study completion, an average of 3 years
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
Measured: Through study completion, an average of 3 years
Discrimination capacity for colorectal cancer
To compare the discrimination capacity of the miRFec score and fecal hemoglobin concentration for the detection of colorectal cancer
Measured: Through study completion, an average of 3 years
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
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start23 Mar 2022
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 5,390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoni Castells, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Antoni Castells, MD, PhD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346757
- Sponsor's protocol ID
- miRFec001
- Acronym
- miRFec
- Status last verified
- Mar 2025
- First submitted
- 13 Apr 2022
- Last updated
- 13 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data that underlie results in a publication
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.
PubMed 31622624Duran-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.
PubMed 32113893
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Comparative, Paired Study to Validate a microRNA-based Fecal Test for Colorectal Cancer Screening. The miRFec Study
- ClinicalTrials.gov ID
- NCT05346757
- Acronym / sponsor ID
- miRFec / miRFec001
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,390 participants (estimated)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| miRFec test | Other | Diagnostic Test: miRFec testThe miRFec test corresponds to the combination of fecal hemoglobin concentration and fecal miRNA expression |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| miRFec testThe miRFec test actually corresponds to the combination of fecal hemoglobin concentration (ie. FIT) and fecal miRNA expression | Diagnostic test | miRFec test |
Primary outcome
Sensitivity for advanced colorectal neoplasm
Time frame: Through study completion, an average of 3 years
To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced colorectal neoplasm
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Background: PubMed 31622624Duran-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 publication: PubMed 32113893Duran-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.
- Individual participant dataSharing planned: Yes. All individual participant data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antoni Castells, MD, PhD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing miRFec test in people with Colorectal Cancer, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mireia Diaz (932275703, mdiazc@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity for advanced colorectal neoplasm (time frame: Through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05346757, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.