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Serological Screening of Gastric Cancer in Wuxi Region

Serological Screening of Gastric Cancer in Wuxi Region

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02663427
Enrollment
5000
Registered
2016-01-26
Start date
2016-01-31
Completion date
2018-06-30
Last updated
2016-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stomach Neoplasms

Keywords

pepsinogen Ⅰ, pepsinogen Ⅱ, gastric cancer screening, helicobacter pylori, gastrin

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.

Interventions

DEVICEserological examination and gastroscope

Sponsors

Jiangsu Institute of Nuclear Medicine
CollaboratorOTHER
Wuxi People's Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
detection rate of gastric cancer among all groupthrough study completion, an average of 1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026