Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629051
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
6-year Follow-up Data After the Berberine Intervention Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Placebo-controlled Clinical Study of Berberine Hydrochloride in Preventing Recurrence and Carcinogenesis After Endoscopic Removal of Colorectal Adenomas6-year Retrospective Follow-up Data
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 077 95CI 066-091 p0001 BBR also has a significant preventive effect on all polypoid lesions including adenomas and serrated lesions adjusted RR 078 95CI 066-091 p0002 Does BBR still have a long-term protective effect on the recurrence of CRA after discontinuation Thats 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
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 077 95CI 066-091 p0001 BBR also has a significant preventive effect on all polypoid lesions including adenomas and serrated lesions adjusted RR 078 95CI 066-091 p0002 Does BBR still have a long-term protective effect on the recurrence of CRA after discontinuation Thats 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None