Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT06126120
Status:
COMPLETED
Last Update Posted:
2025-04-30
First Post:
2023-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Colonoscopy Check-up in People With Lynch Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003123', 'term': 'Colorectal Neoplasms, Hereditary Nonpolyposis'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D049914', 'term': 'DNA Repair-Deficiency Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 231}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2023-11-03', 'studyFirstSubmitQcDate': '2023-11-08', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant non-adherence to 2-yearly colonoscopy check-up.', 'timeFrame': '1 day', 'description': "Participant non-adherence to 2-yearly colonoscopy check-up will be assessed on a single occasion, considering participants' three most recent colonoscopy check-ups, measured as a percentage."}], 'secondaryOutcomes': [{'measure': 'The four most important challenges to having colonoscopy check-up for participants.', 'timeFrame': '1 day', 'description': "The four most important challenges to having colonoscopy check-up will be assessed on a single occasion, considering participants' responses in the questionnaire. The questionnaire asks participants to select their most important challenges from a given list, and the top four selections will be considered the most important challenges."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lynch Syndrome', 'Colonoscopy', 'Surveillance'], 'conditions': ['Lynch Syndrome']}, 'descriptionModule': {'briefSummary': "Lynch Syndrome, an inherited condition, increases bowel cancer risk. People with Lynch Syndrome are recommended to have regular colonoscopies where a camera in a tube is used to look inside the bowel for cancer and for polyps (growths that sometimes can become cancerous). UK guidelines recommend that people with Lynch Syndrome have colonoscopy check-up every 2 years after reaching a certain age; however, they face many challenges which make it difficult to have the recommended check-up.\n\nAmong a subset of people with Lynch Syndrome in England, this study will investigate the:\n\n* percentage who are having colonoscopy check-up as recommended by UK guidelines\n* factors influencing whether a person is more/less likely to have the recommended colonoscopy check-up\n* views, experiences, and challenges of living with Lynch Syndrome and colonoscopy check-up\n\nThis study will collect information from people in the 'Lynch Syndrome registry pilot' using a questionnaire. The Cancer Screening and Prevention Research Group (CSPRG) at Imperial College London are conducting the Lynch Syndrome registry pilot, which is recruiting people with Lynch Syndrome who are aged \\>18 years and in the Cancer Prevention Programme 3 (CaPP3) trial, from Nov 2022-Nov 2023.\n\nThis study will include people in the Lynch Syndrome registry pilot who provided consent on the registry pilot consent form to be contacted about future research and are aged ≥25 years. People who have had previous surgery to remove their rectum will be excluded.\n\nThe investigators will use the 'Views, experiences, and challenges of colonoscopy check-up' questionnaire, together with a few pieces of additional information previously collected as part of the Lynch Syndrome registry pilot.\n\nParticipation involves completing the questionnaire only. The study will take approximately one year from administering the questionnaire to sharing results with participants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will include people who are in the Lynch Syndrome registry pilot and meet the eligibility criteria for the present study. The Lynch Syndrome registry pilot is recruiting people with Lynch Syndrome who are aged \\>18 years and in the CaPP3 trial.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People in the Lynch Syndrome registry pilot who have provided consent to be contacted about future research and are aged ≥25 years\n\nExclusion Criteria:\n\n* People who have had surgery involving removal of their rectum'}, 'identificationModule': {'nctId': 'NCT06126120', 'briefTitle': 'Colonoscopy Check-up in People With Lynch Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Prevalence, Determinants, and Challenges of Adherence With Colonoscopy Check-up in People With Lynch Syndrome: a Questionnaire-based Study', 'orgStudyIdInfo': {'id': 'IRAS 329468'}}, 'contactsLocationsModule': {'locations': [{'zip': 'W2 1NY', 'city': 'London', 'country': 'United Kingdom', 'facility': "Cancer Screening and Prevention Research Group (CSPRG), Department of Surgery and Cancer, Queen Elizabeth The Queen Mother (QEQM) Building, St Mary's Hospital, Imperial College London", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Amanda J Cross, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}