Serological Screening of Gastric Cancer in Wuxi Region

Stomach Neoplasms Clinical Trial

Official title:

Serological Screening of Gastric Cancer in Wuxi Region

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02663427
• Other study ID #: Z201501
• Status: Not yet recruiting
• Phase: N/A
• First received: January 17, 2016
• Last updated: January 25, 2016
• Start date: January 2016
• Est. completion date: June 2018

Study information

• Verified date: January 2016
• Source: Wuxi People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Wuxi City in Jiangsu Province
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: June 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Device:
• serological examination and gastroscope

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wuxi People's Hospital	Jiangsu Institute of Nuclear Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection rate of gastric cancer among all group		through study completion, an average of 1 year	No