6-year Follow-up Data After the Berberine Intervention Trial

NCT06629051 | Recruiting DMC

• 1 other identifier: LY2024-232-A
• Study Type: observational
• Target: 891
• Locations: 1 country
• Sites: 1

Brief Summary

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. In 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. The 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.

Conditions

Colorectal Adenoma; Colorectal Cancer Control and Prevention; Colorectal Polyps

Keywords

berberine; colorectal adenoma; colorectal cancer; long term chemoprevention; colorectal polyps

Outcome Measures

Primary Outcomes (1)

• The recurrence rates of traditional colorectal adenomas within the follow-up period of 6 years

  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.

  6 years, 1-3 years, 3-6 years

Secondary Outcomes (2)

• The incidence rates of hyperplastic polyps and serrated adenomas within 6 years after discontinuation of medication

  6 years, 1-3 years, 3-6 years

• Subgroup analyses

  6 years, 1-3 years, 3-6 years

Study Arms (2)

berberine

post-intervention of berberine

Drug: Berberine Hydrochloride

placebo

post-intervention of placebo tablets

Drug: Placebo

Interventions

Berberine Hydrochloride DRUG

post-intervention of berberine

berberine

Placebo DRUG

Looks the same as berberine

placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Seventh Medical Center of PLA Army General Hospital: collaborator
• Zhongshan Hospital Xiamen University: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Tianjin Medical University General Hospital: collaborator
• the Tenth People's Hospital affiliated to Tongji University: collaborator

Study Sites (1)

Renji Hospital, Shanghai Jiao-Tong University School of Medicine

Shanghai, 200127, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jing-Yuan Fang, M.D, Ph.D

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing-Yuan Fang, Professor

CONTACT

021-13918386561; jingyuanfang@sjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division of Gastroenterology & Hepatology, Renji Hospital

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 8, 2024
• Study Start: October 4, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (1)