Lifestyle Intervention for Prevention of Gastric Neoplasm
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|ClinicalTrials.gov Identifier: NCT02679495|
Recruitment Status : Active, not recruiting
First Posted : February 10, 2016
Last Update Posted : October 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stomach Neoplasms||Behavioral: Active measures of lifestyle modification||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants are assigned to lifestyle intervention group or the control group without lifestyle intervention.|
|Masking:||Single (Outcomes Assessor)|
|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|
|Actual Study Start Date :||March 12, 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
Active Comparator: Lifestyle intervention
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.
Behavioral: Active measures of lifestyle modification
No Intervention: No intervention
No meassures are taken to change life style of enrolled patients.
- gastric caner occurrence [ Time Frame: 4 years ]gastric cancer proved by gastroscopy biopsy
- All cause mortality [ Time Frame: 5 years ]
- gastric tissue DNA methylation change of selected genes [ Time Frame: 4 years ]All patients have gastric biopsy through gastroscopy at the enrollment time and the last follow-up. DNA methylation status of selected genes are tested.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679495
|Linyi People's Hospital affiliated to Shandong University|
|Linyi, Shandong, China, 276000|
|Study Chair:||Lin Lu, MD||Shandong University|