NCT02679495

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 7, 2022

Status Verified

May 1, 2022

Enrollment Period

7.7 years

First QC Date

February 5, 2016

Last Update Submit

November 3, 2022

Conditions

Keywords

early gastric cancerlifestyle

Outcome Measures

Primary Outcomes (1)

  • gastric caner occurrence

    gastric cancer proved by gastroscopy biopsy

    4 years

Secondary Outcomes (2)

  • All cause mortality

    5 years

  • gastric tissue DNA methylation change of selected genes

    4 years

Study Arms (2)

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.

Behavioral: Active measures of lifestyle modification

No intervention

NO INTERVENTION

No meassures are taken to change life style of enrolled patients.

Interventions

Lifestyle intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • patients who refuse to change lifestyle according to the trial plan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linyi People's Hospital affiliated to Shandong University

Linyi, Shandong, 276000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Lin Lu, MD

    Shandong University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants are assigned to lifestyle intervention group or the control group without lifestyle intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 5, 2016

First Posted

February 10, 2016

Study Start

March 12, 2015

Primary Completion

December 1, 2022

Study Completion

December 1, 2023

Last Updated

November 7, 2022

Record last verified: 2022-05

Locations