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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03597672
Other study ID # WCH-GC-SIGES-01
Secondary ID 320.2710.1815
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date December 31, 2020

Study information

Verified date July 2018
Source West China Hospital
Contact Jian-Kun Hu, M.D. Ph.D.
Phone 02885422878
Email hujkwch@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

H. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30000
Est. completion date December 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility 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;

Study Design


Locations

Country Name City State
China Jian-Kun Hu Chengdu Sichuan

Sponsors (2)

Lead Sponsor Collaborator
Jian-Kun Hu Xin-Zu Chen

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The number of new cases of gastric carcinoma The new cases of gastric and other epidermal malignant tumor 5 years
Secondary Time of finding nee cases The time during SIGES when finding nee gastric cancer and relative disease 5 years
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