NCT05291728

Brief Summary

This study collect the relevant data of local residents over 20 years old in 11 regions of Shaanxi Province, The basic information of the subjects was collected by filling in the questionnaire, and serum helicobacter pylori antibody detection was completed at the same time. The expert group determined the high-risk population of gastric cancer after comprehensive evaluation. All the high-risk population of gastric cancer without contraindications underwent electronic gastroscopy in the designated hospital after signing the informed consent. By collecting and analyzing data, early gastric cancer screening was completed and a new gastric cancer risk assessment model was established to evaluate the prevalence of dyspepsia, gastroesophageal reflux disease and precancerous lesions in the natural population of Shaanxi Province, as well as helicobacter pylori infection, radical treatment and recurrence rate.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
12,500,000

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress94%
Oct 2020Oct 2026

Study Start

First participant enrolled

October 1, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 23, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

March 23, 2022

Status Verified

February 1, 2022

Enrollment Period

6 years

First QC Date

February 24, 2022

Last Update Submit

March 13, 2022

Conditions

Early Gastric Cancer

Keywords

early GC,Hp infection,FD, GERD , precancerous lesions

Outcome Measures

Primary Outcomes (1)

  • the detection rate of early gastric cancer

    Patients at high risk of gastric cancer were assessed by questionnaire and Hp test results, and then underwent gastroscopy.Then analyse the detection rate of early gastric cancer.

    2020.10.01-2026.10.01

Secondary Outcomes (1)

  • the prevalence of dyspepsia, gastroesophageal reflux disease and precancerous lesions in the natural population of Shaanxi Province, as well as the prevalence of helicobacter pylori infection, radical treatment and recurrence rate.

    2020.10.01-2026.10.01

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study will be carried out in 11 regions of Shaanxi Province from October 2020 to October 2026. Data of permanent resident population (registered population combined with floating population) in the region will be obtained by the local government, and all permanent residents over 20 years old in each region will be identified as the target population. It is preliminarily estimated that the permanent residents over 20 years old in each region of Shaanxi account for about 20%-60% of the total population, and the screening target of permanent residents over 20 years old in each region is finally established in this project.

You may qualify if:

  • Local resident over 20 years old.
  • Obtain verbal informed consent of the subject.

You may not qualify if:

  • Refused to participate in this research project.
  • Questionnaires or serological tests for helicobacter pylori antibodies were not completed.
  • This study was not completed due to other reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second affiliated hospital of xi'an jiaotong university

Xi'an, Shaanxi, 710004, China

RECRUITING

MeSH Terms

Conditions

Stomach NeoplasmsGastroesophageal Reflux

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesEsophageal Motility DisordersDeglutition DisordersEsophageal Diseases

Study Officials

  • jinhai Wang, MD

    Second Affilated Hospital of Xi'an Jiaotong University

    STUDY DIRECTOR

Central Study Contacts

jinhai Wang, MD

CONTACT

029-87679335jinhaiwang@hotmail.com

Rui Wang, MD

CONTACT

15513872291wr951012@163.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2022

First Posted

March 23, 2022

Study Start

October 1, 2020

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

March 23, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)