Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:42 AM
Study NCT ID:
NCT06714318
Status:
RECRUITING
Last Update Posted:
2025-06-18
First Post:
2024-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SMARTER: Using Blood Samples to iMprove FIT-bAsed coloRecTal cancEr scReening
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2024-11-27', 'studyFirstSubmitQcDate': '2024-11-27', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between result of blood test and colonoscopy result in patients screened positive for blood in the stool', 'timeFrame': 'From enrollment in study till 120 days after colonoscopy. The blood sample will be drawn before the colonoscopy and the final diagnosis from the colonoscopy will be registered 120 days after the colonoscopy.', 'description': "The aim is to investigate the individual's chance of being healthy despite a positive test for blood in the stool in the colorectal cancer screening program. The chance of being healthy is estimated from the combined blood sample results and will be compared to the results of the colonoscopy."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'The project aims to investigate whether colorectal cancer screening can be improved using blood tests, thereby reducing the number of unnecessary colonoscopies. The Danish colorectal cancer screening program was implemented in 2014, and currently, all individuals aged 50-74 are invited every two years to participate. Those who test positive for hidden blood in their stool are referred for a colonoscopy. More than a third of the approximately 25,000 colonoscopies performed annually in the screening program can be classified as unnecessary, as they reveal a normal colon. This results in avoidable and unpleasant procedures for individuals and strains healthcare resources.\n\nThe project seeks to reduce the number of these unnecessary colonoscopies by investigating whether blood biomarkers can identify individuals at very low risk of colorectal cancer after a positive stool test for hidden blood. By utilizing blood tests, screening could become more personalized, precise, and resource-efficient for the healthcare system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All citizens referred to a colonoscopy at Vejle Hospital or Hospital Sønderjylland in the colorectal cancer screening program.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participation in the colorectal cancer screening program.\n\nExclusion Criteria:\n\n* Participants are excluded if a colonoscopy is not completed unless this is due to a colorectal cancer obstruction.'}, 'identificationModule': {'nctId': 'NCT06714318', 'briefTitle': 'SMARTER: Using Blood Samples to iMprove FIT-bAsed coloRecTal cancEr scReening', 'organization': {'class': 'OTHER', 'fullName': 'Vejle Hospital'}, 'officialTitle': 'SMARTER: Using Blood Samples to iMprove FIT-bAsed coloRecTal cancEr scReening', 'orgStudyIdInfo': {'id': 'SMARTER'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Screening participants', 'description': 'All citizens referred to colonoscopy at Vejle Hospital or Hospital Sønderjylland in the colorectal cancer screening program are offered to participate in the study. If the participant agrees, they will have blood drawn and sign a declaration of consent before their colonoscopy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6200', 'city': 'Aabenraa', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Line Fly, MD', 'role': 'CONTACT', 'email': 'line.haugaard.fly@rsyd.dk', 'phone': '+45 20367215'}], 'facility': 'Hospital Sønderjylland', 'geoPoint': {'lat': 55.04434, 'lon': 9.41741}}, {'zip': '7100', 'city': 'Vejle', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Line Fly, MD', 'role': 'CONTACT', 'email': 'line.haugaard.fly@rsyd.dk', 'phone': '+4520367215'}], 'facility': 'Vejle Hospital', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}], 'centralContacts': [{'name': 'Line Fly, MD', 'role': 'CONTACT', 'email': 'line.haugaard.fly@rsyd.dk', 'phone': '+4520367215'}], 'overallOfficials': [{'name': 'Jonna Skov Madsen, Prof., MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Biochemistry and Immunology, Lillebaelt Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vejle Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}