Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-02-20 @ 6:03 PM
Study NCT ID:
NCT06703632
Status:
RECRUITING
Last Update Posted:
2025-02-27
First Post:
2024-11-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of PreveCol's Efficiency As a Second Line Method for the Early Colorectal Cancer Detection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Laboratory Technicians'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Low-risk interventional study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4538}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2024-11-19', 'studyFirstSubmitQcDate': '2024-11-21', 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety', 'timeFrame': '12 months', 'description': 'Measure the percentage of adverse events and complications directly/indirectly related to interventions of study.'}], 'primaryOutcomes': [{'measure': 'Diagnostic value', 'timeFrame': '12 months', 'description': 'Value of efficiency through the clinical performance (sensitivity, specificity, positive predictive value and negative predictive value) of PreveCol® after FOBT positive result for detecting neoplastic lesions.'}], 'secondaryOutcomes': [{'measure': 'Diagnostic performance of cancer', 'timeFrame': '12 months', 'description': "Value of PreveCol's efficiency in second line for detecting cancer"}, {'measure': 'Diagnostic performance of lesions', 'timeFrame': '12 months', 'description': "Value of PreveCol's efficiency in second line for advanced lesions"}, {'measure': 'Value of questionnaires into screening programme', 'timeFrame': '12 months', 'description': 'The percentage of number of answers from each preference questions and PREMs'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colorectal cancer', 'screening programme', 'liquid biopsy', 'second line', 'questionnaire'], 'conditions': ['Screening for Colon Cancer', 'Blood Samples', 'Survey and Questionnaire', 'Colorectal Carcinoma', 'Colon Adenocarcinoma', 'Precancerous Lesion of Colon']}, 'referencesModule': {'references': [{'pmid': '36856579', 'type': 'BACKGROUND', 'citation': 'Siegel RL, Wagle NS, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2023. CA Cancer J Clin. 2023 May-Jun;73(3):233-254. doi: 10.3322/caac.21772. Epub 2023 Mar 1.'}, {'pmid': '35914639', 'type': 'BACKGROUND', 'citation': 'Lordick F, Carneiro F, Cascinu S, Fleitas T, Haustermans K, Piessen G, Vogel A, Smyth EC; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Gastric cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2022 Oct;33(10):1005-1020. doi: 10.1016/j.annonc.2022.07.004. Epub 2022 Jul 29. No abstract available.'}, {'pmid': '28973514', 'type': 'BACKGROUND', 'citation': 'Greuter MJE, de Klerk CM, Meijer GA, Dekker E, Coupe VMH. Screening for Colorectal Cancer With Fecal Immunochemical Testing With and Without Postpolypectomy Surveillance Colonoscopy: A Cost-Effectiveness Analysis. Ann Intern Med. 2017 Oct 17;167(8):544-554. doi: 10.7326/M16-2891. Epub 2017 Oct 3.'}, {'pmid': '25856688', 'type': 'BACKGROUND', 'citation': 'Bujanda L, Sarasqueta C, Castells A, Pellise M, Cubiella J, Gil I, Cosme A, Arana-Arri E, Mar I, Idigoras I, Portillo I; EUSCOLON Study Investigators. Colorectal cancer in a second round after a negative faecal immunochemical test. Eur J Gastroenterol Hepatol. 2015 Jul;27(7):813-8. doi: 10.1097/MEG.0000000000000366.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this low-risk interventional study is to evaluate whether the PreveCol® test has sufficient efficiency to be considered as a second-line method for the detection of both colorectal cancer and advanced adenomas when used prospectively in the screening population with a previous positive FOBT result, which could include any of the following: both sexes, age 50-69 years, asympthomatic volunteers. The main aims to be answered are:\n\n* Values of efficacy, efficiency, impact and safety of PreveCol.\n* Values of preferences of participants for screening methods.\n* Values of PREMs into screening programme.\n\nParticipants will provide a blood sample prior to a screening colonoscopy, and complete two questionnaires. They will give their sample, information and clinical data to the investigator or health care personnel.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants ages from 50 to 69 years (both included) at the time of informed consent signed.\n* Participants should sign an informed consent. They must understand the nature, significance, implications, and risks of the clinical study before signing the informed consent form.\n* Participants with a positive result of FIT/FOBT analysis referred to the gastroenterology department who are eligible to undertake colonoscopy as a regular procedure of the colorectal cancer screening programme.\n* Participants asymptomatic, average risk for CRC. Average risk is defined as those individuals who are age 50 or over with no history of adenoma, colorectal cancer, or inflammatory bowel disease, and with no family history of CRC (first degree relatives).\n\nExclusion Criteria:\n\n* Participants who have developed any another type of cancer in the 5 years prior to their participation in the study.\n* Participants who have previously received chemotherapy or radiotherapy (5 years).\n* Participants previously or currently diagnosed with Familiar Adenomatous Polyposis or Lynch Syndrome or Inflammatory Bowel Disease.\n* Inadequate intestinal preparation for colonoscopy with BBPS score ≤1 in any colon section, excluding diagnostic of CRC.\n* Participants who have undergone polypectomy in the previous 5 years.\n* Hemolysis of blood sample or absence of blood sample.\n* Participants who are arrested at judicial or official request\n* Participants who are in a dependent personal or non-medical relationship with the Sponsor or the investigator.'}, 'identificationModule': {'nctId': 'NCT06703632', 'acronym': 'MS-Prevecol', 'briefTitle': "Evaluation of PreveCol's Efficiency As a Second Line Method for the Early Colorectal Cancer Detection", 'organization': {'class': 'INDUSTRY', 'fullName': 'ADVANCED MARKER DISCOVERY S.L.'}, 'officialTitle': "Evaluation of PreveCol's Efficiency As a Second Line Method for the Early Colorectal Cancer Detection", 'orgStudyIdInfo': {'id': 'AMD-CCR-2024-02'}, 'secondaryIdInfos': [{'id': '2024-NDMH-5101_240046', 'type': 'OTHER_GRANT', 'domain': 'EIT-Health'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PreveCol test after a FOBT positive result', 'description': 'Average-risk participants from the colorectal cancer screening programme with FOBT positive result who are eligible to undergo colonoscopy', 'interventionNames': ['Diagnostic Test: blood sampling', 'Other: Survey using a questionnaire.']}], 'interventions': [{'name': 'blood sampling', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['PreveCol'], 'description': 'PreveCol test based on blood sampling', 'armGroupLabels': ['PreveCol test after a FOBT positive result']}, {'name': 'Survey using a questionnaire.', 'type': 'OTHER', 'description': 'Preference questionnaire for colorectal cancer screening methods', 'armGroupLabels': ['PreveCol test after a FOBT positive result']}, {'name': 'Survey using a questionnaire.', 'type': 'OTHER', 'description': 'PREMs for colorectal cancer screening programme', 'armGroupLabels': ['PreveCol test after a FOBT positive result']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lisbon', 'state': 'Lisbon District', 'status': 'NOT_YET_RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Ana Rita, MD', 'role': 'CONTACT'}], 'facility': 'Hospital de Santa Maria', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'Madrid', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Agustin Albillos, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Ramon y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Marta Jimenez, PhD', 'role': 'CONTACT', 'email': 'mjimenez@amadix.com', 'phone': '+34 637899149'}], 'overallOfficials': [{'name': 'Agustin Albillos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Ramon y Cajal'}, {'name': 'Ana Rita, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Santa Maria'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ADVANCED MARKER DISCOVERY S.L.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hospital Universitario Ramon y Cajal', 'class': 'OTHER'}, {'name': 'Hospital de Santa Maria, Lisbon', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}