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Recruiting NCT06629051

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

— Observational Colorectal Adenoma Colorectal Cancer Control and Prevention Colorectal Polyps

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Berberine Hydrochloride, Placebo.
Who it may be relevant to
Registry conditions: Colorectal Adenoma, Colorectal Cancer Control and Prevention, Colorectal Polyps. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Berberine Hydrochloride
    post-intervention of berberine
  • Drug Placebo
    Looks the same as berberine

Primary outcome measures

  • The recurrence rates of traditional colorectal adenomas within the follow-up period of 6 years [Time frame: 6 years, 1-3 years, 3-6 years]
Secondary outcome measures (2)
  • The incidence rates of hyperplastic polyps and serrated adenomas within 6 years after discontinuation of medication [Time frame: 6 years, 1-3 years, 3-6 years]
  • Subgroup analyses [Time frame: 6 years, 1-3 years, 3-6 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Renji Hospital, Shanghai Jiao-Tong University School of Medicine — Shanghai

Identifiers

NCT: NCT06629051 · LY2024-232-A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗