Serological Screening of Gastric Cancer in Wuxi Region

NCT ID: NCT02663427

Last Updated: 2016-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 5000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-06-30

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.

Conditions

Stomach Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PG(+) and Hp(-) Group

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.

Group Type: EXPERIMENTAL

serological examination and gastroscope

Intervention Type: DEVICE

PG(-) and Hp(-) Group

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.

Group Type: EXPERIMENTAL

serological examination and gastroscope

Intervention Type: DEVICE

PG(-) and Hp(+) Group

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.

Group Type: EXPERIMENTAL

serological examination and gastroscope

Intervention Type: DEVICE

PG(+) and Hp(+) Group

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.

Group Type: EXPERIMENTAL

serological examination and gastroscope

Intervention Type: DEVICE

Interventions

serological examination and gastroscope

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Institute of Nuclear Medicine

OTHER

Sponsor Role: collaborator

Wuxi People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Z201501

Identifier Type: -

Identifier Source: org_study_id