Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 12:09 AM
Study NCT ID:
NCT07353632
Status:
RECRUITING
Last Update Posted:
2026-01-20
First Post:
2025-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
What Influence Re-participation in the Danish Colorectal Screening Program.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8000}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-19', 'studyFirstSubmitDate': '2025-12-29', 'studyFirstSubmitQcDate': '2026-01-19', 'lastUpdatePostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain experienced during colonoscopy, reported by the patient', 'timeFrame': 'apr. 15min after colonoscopy', 'description': '11-point numerical rating scale ranging from 0 (least pain) to 10(most pain)'}], 'secondaryOutcomes': [{'measure': 'Re-participation in screening', 'timeFrame': '2 years following colonoscopy', 'description': '2-year Re-participation rate for those calssified as low risk after index colonoscopy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Screening colonoscopy experience', 'Colorectal cancer screening', 'Patient-reported outcomes', 'Pain perception during colonoscopy', 'Screening re-participation'], 'conditions': ['Colonoscopy', 'Screening Colonscopy', 'Pain']}, 'descriptionModule': {'briefSummary': 'This prospective observational study investigates how participants experience screening colonoscopy within the Danish colorectal cancer screening program and how these experiences relate to clinical findings, procedural factors, and future participation in screening.\n\nThe study aims to evaluate patient-reported experiences such as pain, discomfort, preparation burden, emotional responses, and perceptions of healthcare staff, as well as staff-assessed pain during the procedure. These experiences will be examined in relation to colonoscopy findings, including polyp detection, histology, risk stratification, and colorectal cancer detection. In addition, procedure-specific variables such as insertion time, bowel preparation quality, completeness of colonoscopy, medication use, and adenoma detection rate will be analyzed in relation to patient experience.\n\nA key focus is whether the experience of screening colonoscopy influences subsequent participation in the colorectal cancer screening program, particularly among individuals classified as low risk and re-invited for screening after two years. Registry-based follow-up will be used to assess re-participation.\n\nData are collected prospectively from two sources: (1) real-time procedure data entered by healthcare staff during colonoscopy and (2) patient-reported outcomes collected via a questionnaire completed shortly after the procedure. Additional outcome data are obtained from electronic medical records and national health and screening registries.\n\nThe study has no single predefined hypothesis. Instead, it serves as a data-generating platform designed to address both predefined and future research questions related to screening colonoscopy experiences, quality indicators, and screening adherence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults undergoing a screening colonoscpy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults undergoing screening-derived colonoscopy as part of the Danish colorectal cancer screening program\n* Written informed consent\n\nExclusion Criteria:\n\n* Inability to understand or communicate in Danish\n* Lack of decision-making capacity, including cognitive impairment due to dementia or brain injury\n* Declines or withdraws informed consent'}, 'identificationModule': {'nctId': 'NCT07353632', 'briefTitle': 'What Influence Re-participation in the Danish Colorectal Screening Program.', 'organization': {'class': 'OTHER', 'fullName': 'Esbjerg Hospital - University Hospital of Southern Denmark'}, 'officialTitle': 'Re-participation for Screening-colonoscopy - Experience of colonoscpy_1', 'orgStudyIdInfo': {'id': '24/34903'}}, 'contactsLocationsModule': {'locations': [{'city': 'Aabenraa', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Sygehus Sønderjylland, University hospital of Southern Denmark', 'geoPoint': {'lat': 55.04434, 'lon': 9.41741}}, {'zip': '6700', 'city': 'Esbjerg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Magnus Ploug, phd', 'role': 'CONTACT', 'email': 'magnus.ploug@rsyd.dk', 'phone': '+45 26175029'}], 'facility': 'Esbjerg Hospital, University Hospital of Southern Denmark', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}, {'zip': '7200', 'city': 'Grindsted', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Grindsted Sygehus', 'geoPoint': {'lat': 55.75726, 'lon': 8.9275}}, {'city': 'Gødstrup', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Regionshospitalet Gødstrup', 'geoPoint': {'lat': 56.15584, 'lon': 8.89276}}, {'city': 'Holbæk', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Holbæk Sygehus', 'geoPoint': {'lat': 55.7175, 'lon': 11.71279}}, {'city': 'Køge', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Sjællands Universitetshospital Køge', 'geoPoint': {'lat': 55.45802, 'lon': 12.18214}}, {'city': 'Nykøbing Falster', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Sjællands Universitetshospital, Nykøbing', 'geoPoint': {'lat': 54.76906, 'lon': 11.87425}}, {'city': 'Slagelse', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Slagelse Sygehus', 'geoPoint': {'lat': 55.40276, 'lon': 11.35459}}], 'centralContacts': [{'name': 'Magnus Ploug, phd', 'role': 'CONTACT', 'email': 'magnus.ploug@rsyd.dk', 'phone': '+45 26175029'}, {'name': 'Anitta Øhlenschlæger, Research secretary', 'role': 'CONTACT', 'email': 'SVS-Forskning@rsyd.dk', 'phone': '+45 21 33 86 07'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Esbjerg Hospital - University Hospital of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'OPEN, Open Patient data Explorative Network, Odense University Hospital, Region of Southern Denmark', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}