Stomach NeoplasmsNCT02679495
Lifestyle Intervention for Prevention of Gastric Neoplasm
A study testing Active measures of lifestyle modification in people with Stomach Neoplasms, run by Shandong University at 1 site in China.
Trial summary
The purpose of this study is to determine whether positive lifestyle interventions (diet modification and smoking cessation) are effective in the prevention of gastric pre-cancer and cancer occurrences and reccurence of gastric cancer after endoscopic resection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Active measures of lifestyle modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2015to Dec 2023
- Phase
- Interventional
- 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
Who may be able to join
- diagnosis of chronic atrophy gastritis proved by gastroscopy biopsy pathology or early gastric cancer patients who have recieved endoscopic resection
- have one or several bad lifestyle habits such as eating too much salt, eating too few fruits, smoking, drinking wine, and lack of sleep.
Who cannot join
- patients who refuse to change lifestyle according to the trial plan
Trial locations and contacts
1 site in 1 country.
China1 site
Linyi People's Hospital affiliated to Shandong University
Linyi, Shandong, 276000
About this study
Official title: Positive Lifestyle Interventions for the Prevention of Gastric Pre-cancer and Cancer Occurrences in Patients With Chronic Atrophy Gastritis and Reccurence of Gastric Cancer After Endoscopic Resection
The purpose of this study is to determine whether positive lifestyle interventions (diet modification and smoking cessation) are effective in the prevention of gastric pre-cancer and cancer occurrences and reccurence of gastric cancer after endoscopic resection.
- Conditions
- Stomach Neoplasms
- Being tested
- Active measures of lifestyle modification
- Keywords
- early gastric cancer, lifestyle
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active measures of lifestyle modificationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention | Active comparator | A better lifestyle that are supposed to prevent gastric cancer occurrence are advised to patients. Measures includes dietary change and cessation of smoking and alcohol abuse. Behavioural and cognitive strategies from investigators are performed to patients to ensure adherence to established intervention. Receives: Behavioral: Active measures of lifestyle modification |
| No intervention | No intervention | No meassures are taken to change life style of enrolled patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
gastric caner occurrence
gastric cancer proved by gastroscopy biopsy
Measured: 4 years
Secondary outcomes (2)
All cause mortality
Measured: 5 years
gastric tissue DNA methylation change of selected genes
All patients have gastric biopsy through gastroscopy at the enrollment time and the last follow-up. DNA methylation status of selected genes are tested.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study start12 Mar 2015
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to lifestyle intervention group or the control group without lifestyle intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lijun PENG, MD, Shandong University
- Investigators
- Lin Lu, MD, Study chair, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679495
- Sponsor's protocol ID
- 2015WS0366
- Status last verified
- May 2022
- First submitted
- 5 Feb 2016
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Lifestyle Interventions for the Prevention of Gastric Pre-cancer and Cancer Occurrences in Patients With Chronic Atrophy Gastritis and Reccurence of Gastric Cancer After Endoscopic Resection
- ClinicalTrials.gov ID
- NCT02679495
- Acronym / sponsor ID
- 2015WS0366
- Conditions
- Stomach Neoplasms
- Keywords
- early gastric cancer, lifestyle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 12 Mar 2015 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 10 Feb 2016 (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 purpose of this study is to determine whether positive lifestyle interventions (diet modification and smoking cessation) are effective in the prevention of gastric pre-cancer and cancer occurrences and reccurence of gastric cancer after endoscopic resection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to lifestyle intervention group or the control group without lifestyle intervention.
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention | Active comparator | Behavioral: Active measures of lifestyle modificationA better lifestyle that are supposed to prevent gastric cancer occurrence are advised to patients. Measures includes dietary change and cessation of smoking and alcohol abuse. Behavioural and cognitive strategies from investigators are performed to patients to ensure adherence to established intervention. |
| No intervention | No intervention | –No meassures are taken to change life style of enrolled patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of chronic atrophy gastritis proved by gastroscopy biopsy pathology or early gastric cancer patients who have recieved endoscopic resection
- have one or several bad lifestyle habits such as eating too much salt, eating too few fruits, smoking, drinking wine, and lack of sleep.
Key exclusion criteria (1 listed)
- patients who refuse to change lifestyle according to the trial plan
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 |
|---|---|---|
| Active measures of lifestyle modification | Behavioural | Lifestyle intervention |
Primary outcome
gastric caner occurrence
Time frame: 4 years
gastric cancer proved by gastroscopy biopsy
2 secondary outcomes
All cause mortality
Time frame: 5 years
gastric tissue DNA methylation change of selected genes
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
Lin Lu, MD study chair
Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active measures of lifestyle modification in people with Stomach Neoplasms, run by Shandong University 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 2 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: status not confirmed, as of the sponsor's last update on 7 Nov 2022. 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?
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?
gastric caner occurrence (time frame: 4 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 7 Nov 2022.