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Screening for Early Gastric Cancer in Shaanxi Province

Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05291728
Collaborator
(none)
12,500,000
Enrollment
1
Location
72
Anticipated Duration (Months)
173650.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    From October 2020 to October 2026, after obtaining the informed consent of local residents over 20 years old in 11 regions of Shaanxi Province, the subjects' social demographic characteristics, living and eating habits, and previous diseases were collected by filling in questionnaires, and serum helicobacter pylori antibody was detected at the same time. After comprehensive assessment by the expert group, the high-risk population of gastric cancer was determined. All high-risk population of gastric cancer without contraindications underwent electronic gastroscopy in designated hospitals after signing 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. In this project, the research group was responsible for formulating the plan, designing the questionnaire, and conducting quality control and grass-roots guidance tour. Guanghua Science and Technology Foundation provided public welfare assistance, and distributed and collected questionnaires with the assistance of grass-roots clinics. Finally, the research group sorted out and analyzed the data.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    12500000 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Screening for Early Gastric Cancer in Shaanxi Province
    Actual Study Start Date :
    Oct 1, 2020
    Anticipated Primary Completion Date :
    Oct 1, 2026
    Anticipated Study Completion Date :
    Oct 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. the detection rate of early gastric cancer [2020.10.01-2026.10.01]

      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.

    Secondary Outcome Measures

    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]

      Basic information, Hp antibody detection results and gastroscopy results were collected,and then analyse 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Local resident over 20 years old.

    • Obtain verbal informed consent of the subject.

    Exclusion Criteria:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The second affiliated hospital of xi'an jiaotong university Xi'an Shaanxi China 710004

    Sponsors and Collaborators

    • Second Affiliated Hospital of Xi'an Jiaotong University

    Investigators

    • Study Director: jinhai Wang, MD, Second Affilated Hospital of Xi'an Jiaotong University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Second Affiliated Hospital of Xi'an Jiaotong University
    ClinicalTrials.gov Identifier:
    NCT05291728
    Other Study ID Numbers:
    • 2021036
    First Posted:
    Mar 23, 2022
    Last Update Posted:
    Mar 23, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Second Affiliated Hospital of Xi'an Jiaotong University
    early GC,Hp infection,FD, GERD , precancerous lesions
    Additional relevant MeSH terms:
    Stomach Neoplasms

    Study Results

    No Results Posted as of Mar 23, 2022