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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Polyps; Colorectal Adenoma; Colorectal Cancer Control and Prevention
• Intervention / Treatment: Drug: Berberine Hydrochloride; Drug: Placebo

• Study Type: Observational
• Enrollment (Estimated): 891

Contacts and Locations

• Study Contact: Name: Jing-Yuan Fang, Professor; Phone Number: 021-13918386561; Email: jingyuanfang@sjtu.edu.cn

Study Locations

• China
  • Shanghai, China, 200127
    • Recruiting
    • Renji Hospital, Shanghai Jiao-Tong University School of Medicine
    • Contact: Yun-Yue Guo; Phone Number: 021-68383312; Email: guoyunyue@renji.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria: participants who completed the previous berberine intervention study (NCT02226185) Exclusion Criteria: no

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
berberine; post-intervention of berberine	Drug: Berberine Hydrochloride; post-intervention of berberine
placebo; post-intervention of placebo tablets	Drug: Placebo; Looks the same as berberine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence rates of hyperplastic polyps and serrated adenomas within 6 years after discontinuation of medication	The recurrence rates within the first year, 1-3 years, 3-6 years, and the entire follow-up period of 6 years.	6 years, 1-3 years, 3-6 years
Subgroup analyses	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.	6 years, 1-3 years, 3-6 years

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborators: Zhongshan Hospital Xiamen University; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Tianjin Medical University General Hospital; Seventh Medical Center of PLA Army General Hospital; Nanfang Hospital, Southern Medical University; the Tenth People's Hospital affiliated to Tongji University
• Investigators: Principal Investigator: Jing-Yuan Fang, M.D, Ph.D, Renji Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 4, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 3, 2024
• First Submitted That Met QC Criteria: October 4, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 4, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: colorectal cancer; colorectal polyps; berberine; colorectal adenoma; long term chemoprevention
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenoma
• Other Study ID Numbers: LY2024-232-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All included IPD
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No