Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-03-06 @ 5:28 PM
Study NCT ID:
NCT05346757
Status:
RECRUITING
Last Update Posted:
2025-03-13
First Post:
2022-04-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a microRNA-based Fecal (miRFec) Test for Colorectal Cancer Screening, Surveillance and Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-02-05', 'size': 1148962, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_002.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-03-11T05:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5390}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2022-04-13', 'studyFirstSubmitQcDate': '2022-04-21', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity for advanced colorectal neoplasm', 'timeFrame': 'Through study completion, an average of 3 years', 'description': 'To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced colorectal neoplasm'}], 'secondaryOutcomes': [{'measure': 'Specificity', 'timeFrame': 'Through study completion, an average of 3 years', 'description': 'To compare the specificity of the miRFec test with respect to FIT'}, {'measure': 'Sensitivity for colorectal cancer', 'timeFrame': 'Through study completion, an average of 3 years', 'description': 'To compare the sensitivity of the miRFec test with respect to FIT for the detection of colorectal cancer'}, {'measure': 'Sensitivity for advanced adenomas', 'timeFrame': 'Through study completion, an average of 3 years', 'description': 'To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced adenomas'}, {'measure': 'Sensitivity for advanced serrated lesions', 'timeFrame': 'Through study completion, an average of 3 years', 'description': 'To compare the sensitivity of the miRFec test with respect to FIT for the detection of advanced serrated lesions'}, {'measure': 'Detection rate for advanced colorectal neoplasm', 'timeFrame': 'Through study completion, an average of 3 years', 'description': 'To compare the detection rate for advanced colorectal neoplasm of the miRFec test with respect to FIT'}, {'measure': 'Discrimination capacity for advanced colorectal neoplasms', 'timeFrame': 'Through study completion, an average of 3 years', 'description': 'To compare the discrimination capacity of the miRFec score and fecal hemoglobin concentration for the detection of advanced colorectal neoplasm'}, {'measure': 'Discrimination capacity for colorectal cancer', 'timeFrame': 'Through study completion, an average of 3 years', 'description': 'To compare the discrimination capacity of the miRFec score and fecal hemoglobin concentration for the detection of colorectal cancer'}, {'measure': 'Cost-effectiveness for advanced colorectal neoplasm detection', 'timeFrame': 'Through study completion, an average of 3 years', 'description': 'To compare the cost (euros) for detecting one advanced colorectal neoplasm using the miRFec test with respect to the corresponding figure using FIT'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '31622624', 'type': 'BACKGROUND', '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.'}, {'pmid': '32113893', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 50 to 75 (average-risk) referred to colonoscopy-based CRC screening.\n* Male or female aged 30 to 80 with family history of CRC (moderate-risk) referred to colonoscopy-based CRC screening.\n* Male and female aged 18 or older with personal history of colorectal polyps referred to colonoscopy surveillance.\n* Male and female aged 18 or older with personal history of CRC referred to colonoscopy surveillance.\n* Male and female aged 18 or older with colorectal symptoms referred to diagnostic colonoscopy.\n\nExclusion Criteria:\n\n* Lack of informed consent to participate\n* Personal history of Lynch syndrome\n* Personal history of adenomatous or hamartomatous polyposis\n* Personal history of serrated polyposis syndrome\n* Personal history of inflammatory bowel disease\n* Personal history of total colectomy for any reason\n* Family history of Lynch syndrome\n* Family history of adenomatous or hamartomatous polyposis\n* Family history of serrated polyposis syndrome'}, 'identificationModule': {'nctId': 'NCT05346757', 'acronym': 'miRFec', 'briefTitle': 'Validation of a microRNA-based Fecal (miRFec) Test for Colorectal Cancer Screening, Surveillance and Diagnosis', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Clinic per a la Recerca Biomédica'}, 'officialTitle': 'Prospective, Multicenter, Comparative, Paired Study to Validate a microRNA-based Fecal Test for Colorectal Cancer Screening. The miRFec Study', 'orgStudyIdInfo': {'id': 'miRFec001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'miRFec test', 'description': 'The miRFec test corresponds to the combination of fecal hemoglobin concentration and fecal miRNA expression', 'interventionNames': ['Diagnostic Test: miRFec test']}], 'interventions': [{'name': 'miRFec test', 'type': 'DIAGNOSTIC_TEST', 'description': 'The miRFec test actually corresponds to the combination of fecal hemoglobin concentration (ie. FIT) and fecal miRNA expression', 'armGroupLabels': ['miRFec test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Mireia Diaz', 'role': 'CONTACT', 'email': 'mdiazc@clinic.cat', 'phone': '+34932275703'}], 'facility': 'Hospital Clinic of Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Mireia Diaz', 'role': 'CONTACT', 'email': 'mdiazc@clinic.cat', 'phone': '932275703'}], 'overallOfficials': [{'name': 'Antoni Castells, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic of Barcelona'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of the study', 'ipdSharing': 'YES', 'description': 'All individual participant data that underlie results in a publication', 'accessCriteria': "Request to the study's principal investigator"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion Clinic per a la Recerca Biomédica', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Antoni Castells', 'investigatorAffiliation': 'Fundacion Clinic per a la Recerca Biomédica'}}}}