Clinical trial NCT03597672: Early Detection and Screening Strategy of Gatric Cancer in Sichuan Province-A Prospective Cohort Study (WCH-GC-SIGES-01)
Official title: A Prospective Cohort Study of Early Detection and Screening Strategy for Gatric Cancer in Sichuan Province China (SIGES-01)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neoplasm, Stomach
H. Pylori Infection
Chronic Atrophic Gastritis
Keywords: Gastric carcinoma
Early diagnosis
screening stragety
health population cohort
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: Xin-Zu Chen
First posted: 2018-07-24
Enrollment: 30000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In our study, the poplatiion was enrolled among health inhabitant in Sichuan province in China. People who underwent physical examination in our center who statisfy our indications will be introdeced to participate in our study. The informed consent will be endosed and the blood sample will be collected.

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.

Detailed 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.

Eligibility criteria: 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;

Primary outcomes:
measure: The number of new cases of gastric carcinoma
timeFrame: 5 years
Secondary outcomes:
measure: Time of finding nee cases
timeFrame: 5 years
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Jian-Kun Hu
state: Sichuan
Study officials:
References: