Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-02-20 @ 6:38 PM
Study NCT ID:
NCT06712095
Status:
RECRUITING
Last Update Posted:
2024-12-05
First Post:
2024-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Video Capsule Examination in Patients With Lynch Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003123', 'term': 'Colorectal Neoplasms, Hereditary Nonpolyposis'}, {'id': 'D016864', 'term': 'Li-Fraumeni Syndrome'}, {'id': 'D006223', 'term': 'Hamartoma Syndrome, Multiple'}], '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'}, {'id': 'D006222', 'term': 'Hamartoma'}, {'id': 'D009378', 'term': 'Neoplasms, Multiple Primary'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D003113', 'term': 'Colonoscopy'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2024-11-26', 'studyFirstSubmitQcDate': '2024-11-29', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of paired images the bioinformatician assesses as useful for the development of algorithm', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'The proportion of patients at high-risk as defined by inclusion criteria who agree to undergo video capsule examination.', 'timeFrame': '18 months'}, {'measure': 'The proportion of patients who undergo both video capsule examination and colonoscopy, from whom it is possible to obtain paired images', 'timeFrame': '18 months'}, {'measure': 'The description of any adverse events collected for the Pillcam procedure.', 'timeFrame': '18 months', 'description': 'All adverse events will be collected using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lynch Syndrome', 'Li Fraumeni Syndrome', 'PTEN Hamartoma Syndrome', 'FAP', 'MUTYH Biallelic Mutation', 'STK11 Mutation', 'CDH1 Gene Mutation', 'CHEK2 Gene Mutation', 'BMPR1A Gene Mutation', 'SMAD4 Gene Mutation']}, 'descriptionModule': {'briefSummary': 'Surveillance for colorectal cancer (CRC) in patients predisposed to develop CRC during their lifetime has been impacted by access to colonoscopy suites and endoscopy specialists in the past couple of years. An alternative method, namely the colon capsule, has been proposed, however this investigation is time consuming for the clinician and the images require up to one hour (30-60 minutes) reading to issue a result. The investigators propose to obtain images from paired colonoscopies and colon capsules with the purpose of developing an AI algorithm which could aid the clinicians in reading the colon and expand access to this investigation.\n\nThe main aim of the study is to determine whether it is possible to obtain usable paired images from patients with Lynch and other cancer predisposition syndromes. This will depend on the willingness of the patients to take part in the study and the technical ability of obtaining data from paired images of colonoscopies and colon capsule.\n\nAt recruitment, participants will undergo a colon capsule investigation, followed by a routine colonoscopy as per their normal standard of care. Paired endoscopic images from colonoscopies and colon capsules will be collected and anonymised data will be accessed by the bioinformatician for analysis.\n\nIf the study will be successful in reaching the primary endpoint, further trials will be opened, allowing for a larger population to be included and to obtain more robust data, which eventually can lead to validated AI algorithms and application of computer-aided video-capsules examination as a screening tool in at-risk population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over the age of 18 years old with no active cancer\n* No previous resection of the colon and/or rectum\n* Carriers of a pathogenic/likely pathogenic variant in any of the following cancer-predisposition genes: Lynch syndrome (MLH1, MSH2, MSH6, PMS2), APC (FAP syndrome); biallelic MUTYH; STK11 (Peutz-Jeghers syndrome); PTEN, CDH1, CHEK2, TP53, BMPR1A and SMAD4 (Juvenile polyposis syndrome)\n* Able to consent to the study and undergo colonoscopy.\n\nExclusion Criteria:\n\n* Extensive surgery which poses a high risk of video-capsule blockage or narrowing of the bowel due to extensive tumour. Extensive surgery implies any removal of large portions of the small or large bowel that might cause a narrowing (stricture) in the digestive tract.\n* Previous irradiation to abdomen or pelvis (risk for small bowel obstruction)\n* Carriers of a variant associated with reduced penetrance (in the view of a geneticist) or a variant of uncertain significance.\n* Patients with a PS of 3 or 4 and/or mobility issues\n* Pregnancy\n* Pacemaker or internal electro-medical device (artificial heart valve, cochlear implant or an internal electromedical device).\n* Insulin-dependent diabetes\n* Patients who require deep sedation for colonoscopy'}, 'identificationModule': {'nctId': 'NCT06712095', 'acronym': 'PILLCAM', 'briefTitle': 'Video Capsule Examination in Patients With Lynch Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Royal Marsden NHS Foundation Trust'}, 'officialTitle': 'Video Capsule Examination in Patients With Lynch and Other Cancer-predisposition Syndromes - a Proof-of-concept Study for Obtaining Data to Support the Development of Machine Learning Algorithms to Detect Early Cancers', 'orgStudyIdInfo': {'id': 'CCR5717'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Videocapsule investigation', 'interventionNames': ['Device: Video capsule investigation']}], 'interventions': [{'name': 'Video capsule investigation', 'type': 'DEVICE', 'otherNames': ['Colonoscopy'], 'description': 'Participants will undergo both a video capsule examination and a colonoscopy on the same day.', 'armGroupLabels': ['Videocapsule investigation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW3 6JJ', 'city': 'London', 'state': '(Select)', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Elena Cojocaru, MD', 'role': 'CONTACT', 'email': 'elena.cojocaru@nhs.net', 'phone': '+44 020 7352 8171', 'phoneExt': '2603'}, {'name': 'Lydia Taylor, RN', 'role': 'CONTACT', 'email': 'lydia.taylor@rmh.nhs.uk', 'phone': '+44 020 7352 8171', 'phoneExt': '2603'}, {'name': 'Richard Lee, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Royal Marsden NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Elena Cojocaru, MD', 'role': 'CONTACT', 'email': 'elena.cojocaru@nhs.net', 'phone': '+44 20 7808 2603'}, {'name': 'Lydia Taylor, RN', 'role': 'CONTACT', 'email': 'lydia.taylor@rmh.nhs.uk'}], 'overallOfficials': [{'name': 'Richard Lee, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Marsden NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Marsden NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': "King's College London", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}