Clinical trial NCT06629051: 6-year Follow-up Data After the Berberine Intervention Trial
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Adenoma
Colorectal Cancer Control and Prevention
Colorectal Polyps
Keywords: berberine
colorectal adenoma
colorectal cancer
long term chemoprevention
colorectal polyps
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Seventh Medical Center of PLA Army General Hospital
name: Zhongshan Hospital Xiamen University
name: Nanfang Hospital, Southern Medical University
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Tianjin Medical University General Hospital
name: the Tenth People's Hospital affiliated to Tongji University
First posted: 2024-10-08
Enrollment: 891
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


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

Primary outcomes:
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
Secondary outcomes:
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
measure: Subgroup analyses
timeFrame: 6 years, 1-3 years, 3-6 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiao-Tong University School of Medicine
Study officials:
affiliation: RenJi Hospital
name: Jing-Yuan Fang, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: