Colorectal AdenomaNCT06629051
6-year Follow-up Data After the Berberine Intervention Trial
An observational study of Colorectal Adenoma and Colorectal Cancer Control and Prevention, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Adenoma, Colorectal Cancer Control and Prevention, Colorectal Polyps
- What is being tested?
- Berberine Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 891 participants
- Where
- 1 siteChina
- Study dates
- 4 Oct 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Inclusion Criteria: participants who completed the previous berberine intervention study (NCT02226185) Exclusion Criteria: no
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, Shanghai Jiao-Tong University School of Medicine
Shanghai, 200127
Yun-Yue Guo, 021-68383312, guoyunyue@renji.com
About this study
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
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.
- Being tested
- Berberine Hydrochloride, Placebo
- Keywords
- berberine, colorectal adenoma, colorectal cancer, long term chemoprevention, colorectal polyps
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berberine HydrochlorideDrug
post-intervention of berberine
PlaceboDrug
Looks the same as berberine
| Study group | Role | What they receive |
|---|---|---|
| berberine | post-intervention of berberine Receives: Drug: Berberine Hydrochloride | |
| placebo | post-intervention of placebo tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The recurrence rates within the first year, 1-3 years, 3-6 years, and the entire follow-up period of 6 years.
Measured: 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.
Measured: 6 years, 1-3 years, 3-6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start4 Oct 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 891 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Seventh Medical Center of PLA Army General Hospital, Zhongshan Hospital Xiamen University, Nanfang Hospital, Southern Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Tianjin Medical University General Hospital, the Tenth People's Hospital affiliated to Tongji University
- Responsible party
- Principal investigator, Jing-yuan Fang, MD, Ph. D, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jing-Yuan Fang, M.D, Ph.D, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629051
- Sponsor's protocol ID
- LY2024-232-A
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All included IPD
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06629051
- Acronym / sponsor ID
- LY2024-232-A
- Keywords
- berberine, colorectal adenoma, colorectal cancer, long term chemoprevention, colorectal polyps
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 891 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Seventh Medical Center of PLA Army General Hospital, Zhongshan Hospital Xiamen University, Nanfang Hospital, Southern Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Tianjin Medical University General Hospital, the Tenth People's Hospital affiliated to Tongji University
- Study start
- 4 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| berberine | – | Drug: Berberine Hydrochloridepost-intervention of berberine |
| placebo | – | Drug: Placebopost-intervention of placebo tablets |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Berberine Hydrochloridepost-intervention of berberine | Drug | berberine |
| PlaceboLooks the same as berberine | Drug | placebo |
Primary outcome
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
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.
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: Yes. All included IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing-Yuan Fang, M.D, Ph.D principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Adenoma and Colorectal Cancer Control and Prevention, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing-Yuan Fang, Professor (021-13918386561, jingyuanfang@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.