Serological Screening of Gastric Cancer in Wuxi Region

Not Applicable

• Conditions: Stomach Neoplasms
• Interventions: Device: serological examination and gastroscope

• Registration Number: NCT02663427
• Lead Sponsor: Wuxi People's Hospital

Brief Summary

The purpose of this study is to determine whether detection of pepsinogen Ⅰand Ⅱ combined with Helicobacter pylori antibody, so-called ABC method , is fit on gastric cancer screening in community of Wuxi City.

Detailed Description

Gastric cancer is the third largest cause of cancer related deaths in China with about 350 ,000 gastric cancer-related deaths by gastric cancer in 2012. The studies from Japan and Korea have found gastric cancer screening, especially of the mass population, reduces mortality from gastric cancer, but the data is seldom in China. The ways include radiographic and endoscopic screening, although those methods were shown to reduce gastric cancer mortality, and was recommended as gold standard for population-based screening by Japan and Korea, but many problems have been pointed out: A serious drawback is low uptake of the target population; fear for radiation exposure(0.6 mSv), swallowing unpleasantness due to the use of barium meal, accidental fall during the examination and constipation, causing rare but more serious complications such as intestinal obstruction or diverticulitis after examination may account for the reasons for this low uptake, endoscopic screening is labor-intensive, more costly per examination as complete disinfection of the scope is mandatory, and requires a large number of well-trained experienced endoscopists.

Serological method, so-called ABC method , has been useful as gastric cancer preliminary screening in some areas, such as China, Japan and Korea. The major reasons are attributed to its simplicity, safety (radiation-free, discomfort free), and cost-efficiency. The ABC method is a blood test to stratify the risk of gastric cancer using the combination of H. pylori antibody and pepsinogen I and II, that was documented by large-scale studies in Japan. But the data was short in China, especially in the community.

Study Timeline

• Status Verified: 2016-01
• Study Start: 2016-01
• Study First Submitted: 2016-01-17
• Study First Submitted QC: 2016-01-25
• Last Update Submitted: 2016-01-25
• Study First Posted: 2016-01-26
• Last Update Posted: 2016-01-26
• Primary Completion: 2018-01
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Age 40-70 years old, men and women are not limited, and there are one of the following:

1. Hp infected.
2. Previously suffering from chronic atrophic gastritis, gastric ulcer, gastric polyps, hypertrophic gastritis, pernicious anemia and other precancerous diseases of the stomach.
3. First degree relatives of patients with gastric cancer.
4. Other risk factors for gastric cancer. (high salt, salted diet, smoking, heavy drinking, etc.)

Exclusion Criteria

1. Severe heart, liver, kidney, dysfunction or mental disorders
2. History of gastric surgery (including surgery, minimally invasive EMR, ESD)
3. Use of PPI, acid preparation, stomach protecting agent in the first two weeks
4. The researchers considered inappropriate participants.
5. Informed consent cannot be attained

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PG(-) and Hp(+) Group	serological examination and gastroscope	PG negative and Hp positive. A questionnaire survey are accomplished in 40-70 years old candidates. Eligible subjects are detected PG I and II, Hp-IgG antibody through serological examination. Gastroscope also accomplished in all participants.
PG(-) and Hp(-) Group	serological examination and gastroscope	PG negative （pepsinogen（PG）Ⅰ \> 70ng/ml or PGⅠ/PGⅡ \>7.0）and Hp (helicobacter pylori) negative. A questionnaire survey are accomplished in 40-70 years old candidates. Eligible subjects are detected PG I and II, Hp-IgG antibody through serological examination. Gastroscope also accomplished in all participants.
PG(+) and Hp(-) Group	serological examination and gastroscope	PG positive (PGⅠ ≤ 70ng/ml and PGⅠ/PGⅡ≤7.0) and Hp negative. A questionnaire survey are accomplished in 40-70 years old candidates. Eligible subjects are detected PG I and II, Hp-IgG antibody through serological examination. Gastroscope also accomplished in all participants.
PG(+) and Hp(+) Group	serological examination and gastroscope	PG positive and Hp positive. A questionnaire survey are accomplished in 40-70 years old candidates. Eligible subjects are detected PG I and II, Hp-IgG antibody through serological examination. Gastroscope also accomplished in all participants.

Primary Outcome Measures

Name	Time	Method
detection rate of gastric cancer among all group	through study completion, an average of 1 year