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

H. Pylori Infection Clinical Trial

— SIGES-01  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03597672
• Other study ID #: WCH-GC-SIGES-01
• Secondary ID: 320.2710.1815
• Status: Recruiting
• 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
• 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;

Related Conditions & MeSH terms

• Chronic Atrophic Gastritis
• Gastritis
• Gastritis, Atrophic
• H. Pylori Infection
• Neoplasm, Stomach
• Stomach Neoplasms

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