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Serological Screening of Gastric Cancer in Wuxi Region

Primary Purpose

Stomach Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
serological examination and gastroscope
Sponsored by
Wuxi People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stomach Neoplasms focused on measuring pepsinogen Ⅰ, pepsinogen Ⅱ, gastric cancer screening, helicobacter pylori, gastrin

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    PG(-) and Hp(-) Group

    PG(-) and Hp(+) Group

    PG(+) and Hp(-) Group

    PG(+) and Hp(+) Group

    Arm Description

    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 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 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 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.

    Outcomes

    Primary Outcome Measures

    detection rate of gastric cancer among all group

    Secondary Outcome Measures

    Full Information

    First Posted
    January 17, 2016
    Last Updated
    January 25, 2016
    Sponsor
    Wuxi People's Hospital
    Collaborators
    Jiangsu Institute of Nuclear Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02663427
    Brief Title
    Serological Screening of Gastric Cancer in Wuxi Region
    Official Title
    Serological Screening of Gastric Cancer in Wuxi Region
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    January 2018 (Anticipated)
    Study Completion Date
    June 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wuxi People's Hospital
    Collaborators
    Jiangsu Institute of Nuclear Medicine

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stomach Neoplasms
    Keywords
    pepsinogen Ⅰ, pepsinogen Ⅱ, gastric cancer screening, helicobacter pylori, gastrin

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    5000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PG(-) and Hp(-) Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    PG(-) and Hp(+) Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    PG(+) and Hp(-) Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    PG(+) and Hp(+) Group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    serological examination and gastroscope
    Primary Outcome Measure Information:
    Title
    detection rate of gastric cancer among all group
    Time Frame
    through study completion, an average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 40-70 years old, men and women are not limited, and there are one of the following: Hp infected. Previously suffering from chronic atrophic gastritis, gastric ulcer, gastric polyps, hypertrophic gastritis, pernicious anemia and other precancerous diseases of the stomach. First degree relatives of patients with gastric cancer. Other risk factors for gastric cancer. (high salt, salted diet, smoking, heavy drinking, etc.) Exclusion Criteria: Severe heart, liver, kidney, dysfunction or mental disorders History of gastric surgery (including surgery, minimally invasive EMR, ESD) Use of PPI, acid preparation, stomach protecting agent in the first two weeks The researchers considered inappropriate participants. Informed consent cannot be attained

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Serological Screening of Gastric Cancer in Wuxi Region

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