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Status unknownNCT02663427Updated Jan 26, 2016

Serological Screening of Gastric Cancer in Wuxi Region

An interventional study of serological examination and gastroscope in Stomach Neoplasms, sponsored by Wuxi People's Hospital. Status unknown. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-01-26.

Sponsored by Wuxi People's Hospital · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jan 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
5,000
Allocation
Non-randomized
Ages
40 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stomach Neoplasms

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Keywords

  • pepsinogen Ⅰ
  • pepsinogen Ⅱ
  • gastric cancer screening
  • helicobacter pylori
  • gastrin
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Wuxi People's Hospital is the lead sponsor of 16 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5,000 participants (estimated)

Study arms

  • Experimental
    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.

    Device: serological examination and gastroscope

  • Experimental
    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.

    Device: serological examination and gastroscope

  • Experimental
    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.

    Device: serological examination and gastroscope

  • Experimental
    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.

    Device: serological examination and gastroscope

Interventions

  • Deviceserological examination and gastroscope
06

What researchers measure

Primary outcomes

  1. detection rate of gastric cancer among all group

    Time frame: through study completion, an average of 1 year

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02663427
Lead sponsor
Wuxi People's Hospital
Collaborators
Jiangsu Institute of Nuclear Medicine
Responsible party
Sponsor
First posted
Jan 26, 2016
Start date
Jan 2016
Primary completion
Jan 2018 (estimated)
Completion
Jun 2018 (estimated)
Last update
Jan 26, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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