Precancerous Gastric LesionsPhase 3NCT00339768
A Randomized Multi-Intervention Trial to Inhibit Precancerous Gastric Lesions in Lingu, Shandong Province
A Phase 3 study testing Amoxicillin/omeprazole in people with Precancerous Gastric Lesions, run by National Cancer Institute (NCI) at 1 site in China.
Trial summary
The Division of Cancer Epidemiology and Genetics is conducting a collaborative randomized multi-intervention trial with the Beijing Institute for Cancer Research to evaluate the etiologic role of Helicobacter pylori, garlic, and certain micronutrients in the multi-step process of gastric carcinogenesis. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Precancerous Gastric Lesions
- What is being tested?
- Amoxicillin/omeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,411 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 1995to 10 Jun 1996
- Phase
- Phase 3
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 35-670 in the 14 Linqu villages who received endoscopy examinations in the fall of 1994.
- Both men and women will be included.
- Patients must sign an informed consent form indicating a willingness to participate in the 42-month trial.
- Must be free of debilitating chronic disease.
- Must not report allergies to penicillin or similar medications.
- Must not have had previous treatment for H. pylori.
- Must not have a history of bleeding disorder.
- Must not be taking vitamin/mineral supplements on a regular basis.
Who cannot join
- Persons with cancer (except resected non-melanotic skin cancer), heart failure, emphysema, and other life-threatening illness will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Multi-Intervention Trial to Inhibit Precancerous Gastric Lesions in Lingu, Shandong Province, China
The Division of Cancer Epidemiology and Genetics is conducting a collaborative randomized multi-intervention trial with the Beijing Institute for Cancer Research to evaluate the etiologic role of Helicobacter pylori, garlic, and certain micronutrients in the multi-step process of gastric carcinogenesis. The primary endpoint will not be cancer, but rather the precancerous lesions severe chronic atrophic gastritis, intestinal metaplasia, and dysplasia. The study is designed to detect a stabilizing or mild decrease in the expected age-related progression of precancerous lesions over the course of the trial. Thus the trial can be considered a study of the potential inhibitors of the process of gastric carcinogenesis. The trial will also provide an evaluation of therapy for H. pylori, including an assessment of reinfection rates, a critical need for formulating strategies for infection control in China and other developing countries. Participating in the trial are approximately 3400 adults aged 35-70 who were part of an ongoing survey of precancerous gastric lesions in 13 Linqu villages in Shandong Province. Linqu appears to be an ideal setting for the trial since stomach cancer rates are among the highes in the world, precancerous gastric lesions are prevalent, and the population is stable and well characterized. These individuals will be randomly assigned (taking H. pylori positivity into account) into 8 intervention groups according to a 2(3) factorial design. The interventions are: 1) initial treatment of H. pylori infection with ameprazole and amoxicillin followed by 2) daily supplementation with a combination of alpha-tocopherol, vitamin C, and selenium; and 3) daily supplementation with garlic extracts. No serious side effects have been seen from any of the interventions to date. The study staff will continue to monitor for possible adverse reactions and the population will receive routine medical care follow-up throughout the course of the trial.
As part of the ongoing study in Linqu, all participants received an endoscopic exam in the fall of 1994. Repeat gastroscopic exams with biopsies at 7 standard gastric sites will be conducted during March to May, 1999 and March to May, 2003 to detect early cancers and to evaluate gasatric mucosal status. The subjects will be categorized according to the most advanced lesions detected in all biopsies and assigned a severity score. The three major endpoints for analysis will be: 1) prevalence of dysplasia or cancer 2) prevalence of sever chronic atrophic gastritis, intestinal metaplasia, dysplasia, or cancer; and 3) average severity score.
Read the detailed description
The Division of Cancer Epidemiology and Genetics is conducting an 8-year collaborative randomized multi-intervention trial with the Beijing Institute for Cancer Research to evaluate the etiologic role of Helicobacter pylori, garlic, and certain micronutrients in the multi-step process of gastric carcinogenesis. The primary endpoint will not be cancer, but rather the precancerous lesions severe chronic atrophic gastritis, intestinal metaplasia, and dysplasia. The study is designed to detect a stabilizing or mild decrease in the expected age-related progression of precancerous lesions over the course of the trial. Thus the trial can be considered a study of the potential inhibitors of the process of gastric carcinogenesis. The trial will also provide an evaluation of therapy for H. pylori, including an assessment of reinfection rates, a critical need for formulating strategies for infection control in China and other developing countries. Participating in the trial are approximately 3400 adults aged 35-70 who were part of an ongoing survey of precancerous gastric lesions in 13 Linqu villages in Shandong Province. Linqu appears to be an ideal setting for the trial since stomach cancer rates are among the highest in the world, precancerous gastric lesions are prevalent, and the population is stable and well characterized. These individuals will be randomly assigned (taking H. pylori positivity into account) into 8 intervention groups according to a 2(3) factorial design. The interventions are: 1) initial treatment of H. pylori infection with omeprazole and amoxicillin followed by 2) daily supplementation with a combination of alpha-tocopherol, vitamin C, and selenium; and 3) daily supplementation with garlic extracts. Compliance was excellent and no serious side effects were seen from any of the interventions.
As part of the ongoing study in Linqu, all participants received an endoscopic exam in the fall of 1994. Repeat gastroscopic exams with biopsies at 7 standard gastric sites conducted during March to May, 1999 and March to April, 2003 to detect early cancers and to evaluate gastric mucosal status. The subjects will be categorized according to the most advanced lesions detected in all biopsies and assigned a severity score. The three major endpoints for analysis will be: 1) prevalence of dysplasia or cancer 2) prevalence of severe chronic atrophic gastritis, intestinal metaplasia, dysplasia, or cancer; and 3) average severity score.
The major endpoint paper was published in JNCI in 2006. Additional analyses of the trial data are underway. A continuation study is proceeding that will allow for follow-up of the approximately 3070 remaining trial participants through 2010 on the long-term effects of the previous treatments on gastric cancer incidence and on cause-specific death rates and allow approximately 364 participants in the previous study with advanced gastric lesions in 2003 an opportunity for annual endoscopic screening for gastric cancer.
- Conditions
- Precancerous Gastric Lesions
- Being tested
- Amoxicillin/omeprazole
- Keywords
- Helicobacter Pylori, Gastric Cancer Prevention, Precancerous Gastric Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin/omeprazoleDrug
To treat Helicobacter pylori infections. 2 week course of amoxicillin 1gm bid, omeprazole 20mg bid. This factorial trial also investigated a supplement of vitamin C, vitamin E and selenium and a garlic supplement.
| Study group | Role | What they receive |
|---|---|---|
| Amox/omepr | Experimental | 2 weeks; placebo controlled Receives: Drug: Amoxicillin/omeprazole |
| Garlic | Experimental | Supplement for 7 years; placebo controlled Receives: Drug: Amoxicillin/omeprazole |
| Vitamins | Experimental | Supplement for 7 years; placebo controlled Receives: Drug: Amoxicillin/omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precancerous gastric lesions
prevention of cancer
Measured: 7 years
Gastric cancer incidence
prevention of caner
Measured: 15 years
Secondary outcomes (1)
Side effects
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start1 Jul 1995
- Primary completion10 Jun 1996
- Study completion10 Jun 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Precancerous Gastric LesionsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,411 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mitchell H Gail, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339768
- Sponsor's protocol ID
- 999995029
- Other IDs
- OH95-C-N029
- Status last verified
- 19 Feb 2019
- First submitted
- 19 Jun 2006
- Last updated
- 12 Dec 2019
- Results posted
- No
Publications
Correa P. Human gastric carcinogenesis: a multistep and multifactorial process--First American Cancer Society Award Lecture on Cancer Epidemiology and Prevention. Cancer Res. 1992 Dec 15;52(24):6735-40.
PubMed 1458460You WC, Blot WJ, Chang YS, Ershow AG, Yang ZT, An Q, Henderson B, Xu GW, Fraumeni JF Jr, Wang TG. Diet and high risk of stomach cancer in Shandong, China. Cancer Res. 1988 Jun 15;48(12):3518-23.
PubMed 3370645You WC, Blot WJ, Li JY, Chang YS, Jin ML, Kneller R, Zhang L, Han ZX, Zeng XR, Liu WD, et al. Precancerous gastric lesions in a population at high risk of stomach cancer. Cancer Res. 1993 Mar 15;53(6):1317-21.
PubMed 8443811Su XQ, Yin ZY, Jin QY, Liu ZC, Han X, Hu ZQ, Zhang L, Ma JL, Li ZX, Zhang Y, Zhou T, Liu WD, You WC, Pan KF, Shi L, Li WQ. Allium vegetable intake associated with the risk of incident gastric cancer: a continuous follow-up study of a randomized intervention trial. Am J Clin Nutr. 2023 Jan;117(1):22-32. doi: 10.1016/j.ajcnut.2022.10.017. Epub 2022 Dec 20.
PubMed 36789941Guo Y, Li ZX, Zhang JY, Ma JL, Zhang L, Zhang Y, Zhou T, Liu WD, Han ZX, Li WQ, Pan KF, You WC. Association Between Lifestyle Factors, Vitamin and Garlic Supplementation, and Gastric Cancer Outcomes: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2020 Jun 1;3(6):e206628. doi: 10.1001/jamanetworkopen.2020.6628.
PubMed 32589229Li WQ, Zhang JY, Ma JL, Li ZX, Zhang L, Zhang Y, Guo Y, Zhou T, Li JY, Shen L, Liu WD, Han ZX, Blot WJ, Gail MH, Pan KF, You WC. Effects of Helicobacter pylori treatment and vitamin and garlic supplementation on gastric cancer incidence and mortality: follow-up of a randomized intervention trial. BMJ. 2019 Sep 11;366:l5016. doi: 10.1136/bmj.l5016.
PubMed 31511230
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multi-Intervention Trial to Inhibit Precancerous Gastric Lesions in Lingu, Shandong Province, China
- ClinicalTrials.gov ID
- NCT00339768
- Acronym / sponsor ID
- 999995029
- Conditions
- Precancerous Gastric Lesions
- Keywords
- Helicobacter Pylori, Gastric Cancer Prevention, Precancerous Gastric Lesions
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,411 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 Jul 1995
- Primary completion
- 10 Jun 1996 (actual)
- Study completion
- 10 Jun 1996 (actual)
- First posted
- 21 Jun 2006 (estimated)
- 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.
The Division of Cancer Epidemiology and Genetics is conducting a collaborative randomized multi-intervention trial with the Beijing Institute for Cancer Research to evaluate the etiologic role of Helicobacter pylori, garlic, and certain micronutrients in the multi-step process of gastric carcinogenesis. The primary endpoint will not be cancer, but rather the precancerous lesions severe chronic atrophic gastritis, intestinal metaplasia, and dysplasia. The study is designed to detect a stabilizing or mild decrease in the expected age-related progression of precancerous lesions over the course of the trial. Thus the trial can be considered a study of the potential inhibitors of the process of gastric carcinogenesis. The trial will also provide an evaluation of therapy for H. pylori, including an assessment of reinfection rates, a critical need for formulating strategies for infection control in China and other developing countries. Participating in the trial are approximately 3400 adults aged 35-70 who were part of an ongoing survey of precancerous gastric lesions in 13 Linqu villages in Shandong Province. Linqu appears to be an ideal setting for the trial since stomach cancer rates are among the highes in the world, precancerous gastric lesions are prevalent, and the population is stable and well characterized. These individuals will be randomly assigned (taking H. pylori positivity into account) into 8 intervention groups according to a 2(3) factorial design. The interventions are: 1) initial treatment of H. pylori infection with ameprazole and amoxicillin followed by 2) daily supplementation with a combination of alpha-tocopherol, vitamin C, and selenium; and 3) daily supplementation with garlic extracts. No serious side effects have been seen from any of the interventions to date. The study staff will continue to monitor for possible adverse reactions and the population will receive routine medical care follow-up throughout the course of the trial.
As part of the ongoing study in Linqu, all participants received an endoscopic exam in the fall of 1994. Repeat gastroscopic exams with biopsies at 7 standard gastric sites will be conducted during March to May, 1999 and March to May, 2003 to detect early cancers and to evaluate gasatric mucosal status. The subjects will be categorized according to the most advanced lesions detected in all biopsies and assigned a severity score. The three major endpoints for analysis will be: 1) prevalence of dysplasia or cancer 2) prevalence of sever chronic atrophic gastritis, intestinal metaplasia, dysplasia, or cancer; and 3) average severity score.
Detailed description
The Division of Cancer Epidemiology and Genetics is conducting an 8-year collaborative randomized multi-intervention trial with the Beijing Institute for Cancer Research to evaluate the etiologic role of Helicobacter pylori, garlic, and certain micronutrients in the multi-step process of gastric carcinogenesis. The primary endpoint will not be cancer, but rather the precancerous lesions severe chronic atrophic gastritis, intestinal metaplasia, and dysplasia. The study is designed to detect a stabilizing or mild decrease in the expected age-related progression of precancerous lesions over the course of the trial. Thus the trial can be considered a study of the potential inhibitors of the process of gastric carcinogenesis. The trial will also provide an evaluation of therapy for H. pylori, including an assessment of reinfection rates, a critical need for formulating strategies for infection control in China and other developing countries. Participating in the trial are approximately 3400 adults aged 35-70 who were part of an ongoing survey of precancerous gastric lesions in 13 Linqu villages in Shandong Province. Linqu appears to be an ideal setting for the trial since stomach cancer rates are among the highest in the world, precancerous gastric lesions are prevalent, and the population is stable and well characterized. These individuals will be randomly assigned (taking H. pylori positivity into account) into 8 intervention groups according to a 2(3) factorial design. The interventions are: 1) initial treatment of H. pylori infection with omeprazole and amoxicillin followed by 2) daily supplementation with a combination of alpha-tocopherol, vitamin C, and selenium; and 3) daily supplementation with garlic extracts. Compliance was excellent and no serious side effects were seen from any of the interventions.
As part of the ongoing study in Linqu, all participants received an endoscopic exam in the fall of 1994. Repeat gastroscopic exams with biopsies at 7 standard gastric sites conducted during March to May, 1999 and March to April, 2003 to detect early cancers and to evaluate gastric mucosal status. The subjects will be categorized according to the most advanced lesions detected in all biopsies and assigned a severity score. The three major endpoints for analysis will be: 1) prevalence of dysplasia or cancer 2) prevalence of severe chronic atrophic gastritis, intestinal metaplasia, dysplasia, or cancer; and 3) average severity score.
The major endpoint paper was published in JNCI in 2006. Additional analyses of the trial data are underway. A continuation study is proceeding that will allow for follow-up of the approximately 3070 remaining trial participants through 2010 on the long-term effects of the previous treatments on gastric cancer incidence and on cause-specific death rates and allow approximately 364 participants in the previous study with advanced gastric lesions in 2003 an opportunity for annual endoscopic screening for gastric cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amox/omepr | Experimental | Drug: Amoxicillin/omeprazole2 weeks; placebo controlled |
| Garlic | Experimental | Drug: Amoxicillin/omeprazoleSupplement for 7 years; placebo controlled |
| Vitamins | Experimental | Drug: Amoxicillin/omeprazoleSupplement for 7 years; placebo controlled |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ages 35-670 in the 14 Linqu villages who received endoscopy examinations in the fall of 1994.
- Both men and women will be included.
- Patients must sign an informed consent form indicating a willingness to participate in the 42-month trial.
- Must be free of debilitating chronic disease.
- Must not report allergies to penicillin or similar medications.
Key exclusion criteria (1 listed)
- Persons with cancer (except resected non-melanotic skin cancer), heart failure, emphysema, and other life-threatening illness will be excluded.
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 |
|---|---|---|
| Amoxicillin/omeprazoleTo treat Helicobacter pylori infections. 2 week course of amoxicillin 1gm bid, omeprazole 20mg bid. This factorial trial also investigated a supplement of vitamin C, vitamin E and selenium and a garlic supplement. | Drug | Amox/omepr, Garlic, Vitamins |
Primary outcome
Precancerous gastric lesions
Time frame: 7 years
prevention of cancer
Gastric cancer incidence
Time frame: 15 years
prevention of caner
1 secondary outcome
Side effects
Time frame: 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Background: PubMed 1458460Correa P. Human gastric carcinogenesis: a multistep and multifactorial process--First American Cancer Society Award Lecture on Cancer Epidemiology and Prevention. Cancer Res. 1992 Dec 15;52(24):6735-40.
- Background: PubMed 3370645You WC, Blot WJ, Chang YS, Ershow AG, Yang ZT, An Q, Henderson B, Xu GW, Fraumeni JF Jr, Wang TG. Diet and high risk of stomach cancer in Shandong, China. Cancer Res. 1988 Jun 15;48(12):3518-23.
- Background: PubMed 8443811You WC, Blot WJ, Li JY, Chang YS, Jin ML, Kneller R, Zhang L, Han ZX, Zeng XR, Liu WD, et al. Precancerous gastric lesions in a population at high risk of stomach cancer. Cancer Res. 1993 Mar 15;53(6):1317-21.
- Derived from this study: PubMed 36789941Su XQ, Yin ZY, Jin QY, Liu ZC, Han X, Hu ZQ, Zhang L, Ma JL, Li ZX, Zhang Y, Zhou T, Liu WD, You WC, Pan KF, Shi L, Li WQ. Allium vegetable intake associated with the risk of incident gastric cancer: a continuous follow-up study of a randomized intervention trial. Am J Clin Nutr. 2023 Jan;117(1):22-32. doi: 10.1016/j.ajcnut.2022.10.017. Epub 2022 Dec 20.
- Derived from this study: PubMed 32589229Guo Y, Li ZX, Zhang JY, Ma JL, Zhang L, Zhang Y, Zhou T, Liu WD, Han ZX, Li WQ, Pan KF, You WC. Association Between Lifestyle Factors, Vitamin and Garlic Supplementation, and Gastric Cancer Outcomes: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2020 Jun 1;3(6):e206628. doi: 10.1001/jamanetworkopen.2020.6628.
- Derived from this study: PubMed 31511230Li WQ, Zhang JY, Ma JL, Li ZX, Zhang L, Zhang Y, Guo Y, Zhou T, Li JY, Shen L, Liu WD, Han ZX, Blot WJ, Gail MH, Pan KF, You WC. Effects of Helicobacter pylori treatment and vitamin and garlic supplementation on gastric cancer incidence and mortality: follow-up of a randomized intervention trial. BMJ. 2019 Sep 11;366:l5016. doi: 10.1136/bmj.l5016.
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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.
Mitchell H Gail, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amoxicillin/omeprazole in people with Precancerous Gastric Lesions, run by National Cancer Institute (NCI) at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2019. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Precancerous gastric lesions (time frame: 7 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00339768, which also lists 6 linked publications.
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 12 Dec 2019.