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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| miRFec test | Other | The miRFec test corresponds to the combination of fecal hemoglobin concentration and fecal miRNA expression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| miRFec test | Diagnostic Test | The miRFec test actually corresponds to the combination of fecal hemoglobin concentration (ie. FIT) and fecal miRNA expression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity for advanced colorectal neoplasm | To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced colorectal neoplasm | Through study completion, an average of 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity | To compare the specificity of the miRFec test with respect to FIT | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mireia Diaz | Contact | 932275703 | mdiazc@clinic.cat |
| Name | Affiliation | Role |
|---|---|---|
| Antoni Castells, MD, PhD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic of Barcelona | Recruiting | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31622624 | Background | 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. | |
| 32113893 |
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All individual participant data that underlie results in a publication
After the end of the study
Request to the study's principal investigator
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 5, 2025 | Mar 11, 2025 | Prot_SAP_ICF_002.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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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.
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| 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 | 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 | 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 | 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 | 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 | 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 | Through study completion, an average of 3 years |
| Result |
| 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. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |