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Early Detection and Screening Strategy of Gatric Cancer in Sichuan Province-A Prospective Cohort Study (WCH-GC-SIGES-01)

Sponsor
Jian-Kun Hu (Other)
Overall Status
Unknown status
CT.gov ID
NCT03597672
Collaborator
Xin-Zu Chen (Other)
30,000
Enrollment
1
Location
48
Anticipated Duration (Months)
625.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To establish prospective cohort of healthy population and corresponding serum sample bank in Sichuan province to provide platform for exploring early diagnosis and screening strategy of gastric cancer by a prospective cohort study.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    1. pylori was one of the most important carcinogenic factor for gastric cancer and play a crucial role in inducing gastritis, atrophy and canceration. Chronic atrophic gastritis (CAG) was a common precancerous disease, people with CAG become high-risk population and need regular follow-up. However, study about occurrence risk prediction for gastric cancer when H. pylori infection concurrence with CAG was still spare. In especial, there was still no population screening program based on serology. The relative clinical epidemiology for providing evidence for China gastric cancer screening program was very rare.

    This study aim to evaluate gastric cancer occurrence risk and diagnostic value of people combined with H. pylori infection and CAG by Serological methods in Sichuan province China. We also project to design optimized screening program suitable for people in sichuan province China.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Cohort Study of Early Detection and Screening Strategy for Gatric Cancer in Sichuan Province China (SIGES-01)
    Actual Study Start Date :
    Jan 1, 2017
    Anticipated Primary Completion Date :
    Dec 31, 2019
    Anticipated Study Completion Date :
    Dec 31, 2020

    Outcome Measures

    Primary Outcome Measures

    1. The number of new cases of gastric carcinoma [5 years]

      The new cases of gastric and other epidermal malignant tumor

    Secondary Outcome Measures

    1. Time of finding nee cases [5 years]

      The time during SIGES when finding nee gastric cancer and relative disease

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Inhabitant in Sichuan province in China (length of residence > 10 years);

    2. Complete physical examination in our hospital, the outcomes was asymptomatic and cancer free healthy individuals;

    3. Age between 20 and 70;

    4. With normal cognitive and communication ability;

    5. Without gastroscopy during recruitment, physical examination item including gastroscopy enrolled in prospective cohort study;

    6. Wiling to accept 1-2 times routine physical examination in our hospital;

    7. Agree to accept the follow-up of our project group;

    Exclusion Criteria:

    1. With history of malignant tumor;

    2. Refuse to donate blood specimen;

    3. With serious comorbidity and/or finite life (less than 5 years);

    4. Request to retreat from this study;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jian-Kun Hu Chengdu Sichuan China 610041

    Sponsors and Collaborators

    • Jian-Kun Hu
    • Xin-Zu Chen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jian-Kun Hu, Vice director of Gastrointestinal Surgery department, West China Hospital; Director of Institute of Gastric Cancer, State Key Laboratory of Biotherapy, West China Hospital, West China Hospital
    ClinicalTrials.gov Identifier:
    NCT03597672
    Other Study ID Numbers:
    • WCH-GC-SIGES-01
    • 320.2710.1815
    First Posted:
    Jul 24, 2018
    Last Update Posted:
    Jul 24, 2018
    Last Verified:
    Jul 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jian-Kun Hu, Vice director of Gastrointestinal Surgery department, West China Hospital; Director of Institute of Gastric Cancer, State Key Laboratory of Biotherapy, West China Hospital, West China Hospital
    Gastric carcinoma
    Early diagnosis
    screening stragety
    health population cohort
    Additional relevant MeSH terms:
    Stomach Neoplasms
    Gastritis
    Gastritis, Atrophic

    Study Results

    No Results Posted as of Jul 24, 2018