Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT06629051
Status:
RECRUITING
Last Update Posted:
2024-10-08
First Post:
2024-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
6-year Follow-up Data After the Berberine Intervention Trial
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 891}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-04', 'studyFirstSubmitDate': '2024-10-03', 'studyFirstSubmitQcDate': '2024-10-04', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The recurrence rates of traditional colorectal adenomas within the follow-up period of 6 years', 'timeFrame': '6 years, 1-3 years, 3-6 years', 'description': 'The cumulative recurrence rate of CRAs within the entire follow-up period of 6 years. The recurrence rates of CRAs within the first year, 1-3 years, 3-6 years. The number, size and location of all adenomas are assessed.'}], 'secondaryOutcomes': [{'measure': 'The incidence rates of hyperplastic polyps and serrated adenomas within 6 years after discontinuation of medication', 'timeFrame': '6 years, 1-3 years, 3-6 years', 'description': 'The recurrence rates within the first year, 1-3 years, 3-6 years, and the entire follow-up period of 6 years.'}, {'measure': 'Subgroup analyses', 'timeFrame': '6 years, 1-3 years, 3-6 years', 'description': 'For patients with advanced CRA or high-risk adenomas (including advanced CRA and multiple adenomas≥3），the recurrence rates of CRAs and polyps are further evaluated.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['berberine', 'colorectal adenoma', 'colorectal cancer', 'long term chemoprevention', 'colorectal polyps'], 'conditions': ['Colorectal Adenoma', 'Colorectal Cancer Control and Prevention', 'Colorectal Polyps']}, 'descriptionModule': {'briefSummary': "Colorectal cancer (CRC) is a common malignancy of the digestive tract, which constitutes a major public health burden. Almost 90% of CRC cases progress from precursor adenomatous polyps through adenoma-carcinoma sequence. Endoscopic detection and removal of colorectal adenoma (CRA) could reduce the incidence and mortality risk of CRC, but the recurrence rate is still high. Therefore, chemoprevention is quite important, not only solve the urgent public health problem, but also be cost-effective.\n\nIn 2020, the investigators published a multicenter, randomized, double-blind, placebo-controlled clinical study (NCT02226185) in the Lancet Gastroenterology \\& Hepatology. The result concluded that oral BBR for 2 years significantly reduced recurrence after endoscopic removal of CRA (RR 0.77, 95%CI 0.66-0.91; p=0.001). BBR also has a significant preventive effect on all polypoid lesions, including adenomas and serrated lesions (adjusted RR 0.78, 95%CI 0.66-0.91; p=0.002) . Does BBR still have a long-term protective effect on the recurrence of CRA after discontinuation? That's what the investigators concerned.\n\nThe present study is performed to observe and compare retrospectively the recurrence rate of CRAs in patients of the original BBR RCT study (NCT02226185) within 6 years after discontinuation of medication, including the overall recurrence rate of traditional adenomas within the first year, 1-3 years, 3-6 years, and the entire follow-up period of 6 years. The aim is to evaluate the long-term efficacy of BBR in preventing recurrence and carcinogenesis after endoscopic resection of CRAs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We included 895 participants who completed the previous berberine intervention study (NCT02226185), including 432 participants in the BBR group and 463 participants in the placebo group.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: participants who completed the previous berberine intervention study (NCT02226185) Exclusion Criteria: no'}, 'identificationModule': {'nctId': 'NCT06629051', 'briefTitle': '6-year Follow-up Data After the Berberine Intervention Trial', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'A Multicenter, Placebo-controlled Clinical Study of Berberine Hydrochloride in Preventing Recurrence and Carcinogenesis After Endoscopic Removal of Colorectal Adenomas：6-year Retrospective Follow-up Data', 'orgStudyIdInfo': {'id': 'LY2024-232-A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'berberine', 'description': 'post-intervention of berberine', 'interventionNames': ['Drug: Berberine Hydrochloride']}, {'label': 'placebo', 'description': 'post-intervention of placebo tablets', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Berberine Hydrochloride', 'type': 'DRUG', 'description': 'post-intervention of berberine', 'armGroupLabels': ['berberine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Looks the same as berberine', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yun-Yue Guo', 'role': 'CONTACT', 'email': 'guoyunyue@renji.com', 'phone': '021-68383312'}], 'facility': 'Renji Hospital, Shanghai Jiao-Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jing-Yuan Fang, Professor', 'role': 'CONTACT', 'email': 'jingyuanfang@sjtu.edu.cn', 'phone': '021-13918386561'}], 'overallOfficials': [{'name': 'Jing-Yuan Fang, M.D, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RenJi Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': 'All included IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seventh Medical Center of PLA Army General Hospital', 'class': 'OTHER'}, {'name': 'Zhongshan Hospital Xiamen University', 'class': 'OTHER'}, {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, {'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}, {'name': 'Tianjin Medical University General Hospital', 'class': 'OTHER'}, {'name': "the Tenth People's Hospital affiliated to Tongji University", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Division of Gastroenterology & Hepatology, Renji Hospital', 'investigatorFullName': 'Jing-yuan Fang, MD, Ph. D', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}