Nasal Endoscopic Screening and Risk Assessment for Early Gastric Cancer

July 25, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

China Health Promotion Foundation/the Second Affiliated Hospital of Zhejiang University, School of Medicine

Pepsinogens (PGs) can be used for gastric cancer (GC) screening, but the cutoff levels vary among studies, and PG levels are influenced by numerous factors. To examine the diagnostic value of PG levels and Helicobacter pylori (Hp) status for GC and precancerous lesions screening in asymptomatic individuals undergoing health checkup in China.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Pepsinogens (PGs) can be used for gastric cancer (GC) screening, but the cutoff levels vary among studies, and PG levels are influenced by numerous factors. To examine the diagnostic value of PG levels and Helicobacter pylori (Hp) status for GC and precancerous lesions screening in asymptomatic individuals undergoing health checkup in China. We operated a multicenter cross-sectional study of subjects who underwent health checkup at nine International Healthcare Centers in China. All participants underwent gastroscopy and pathological examination, serum PG, 13C-urea breath test, and/or Hp serological current infection marker rapid test, all on the same day. PG related parameters were analyzed in different Hp subgroups and regions.

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Chinese PLA General Hospital
      • Chengdu, China
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
          • Lirong Gong
      • Chongqing, China
        • Recruiting
        • The First Hospital Affiliated to AMU (SOUTHWEST HOSPITAL)
        • Contact:
          • Hongbo Wu
      • Guilin, China
        • Recruiting
        • No. 924 Hospital of the People's Liberation Army of China
        • Contact:
          • Xueqiang He
      • Jingzhou, China
        • Recruiting
        • Jingzhou Hospital of Traditional Chinese Medicine
        • Contact:
          • Yinhu Luo
      • Kunshan, China
        • Recruiting
        • Kunshan Hospital of Traditional Chinese Medicine
        • Contact:
          • Hongwei Xu
      • Shanghai, China
        • Recruiting
        • Shanghai Changhai Hospital
        • Contact:
          • Dong Wang
      • Xiamen, China
        • Recruiting
        • Zhongshan Hospital Affiliated to Xiamen University
        • Contact:
          • Hongzhi Xu
    • Jilin
      • Jilin, Jilin, China
        • Recruiting
        • Jilin City People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

consecutive subjects who underwent regular health checkup at nine International Healthcare Centers in different regions of China

Description

Inclusion Criteria:

intention to undergo gastroscopy during health checkup examination 25-75 years of age.

Exclusion Criteria:

a history of gastric ulcer, gastric polyp, or GC a history of gastrectomy treatment with a proton pump inhibitor in the last month contraindications to gastroscopy a history of Hp eradication a history of abdominal pain, abdominal distention, belching, acid reflux, nausea and other digestive tract symptoms within 1 month incomplete data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
non-atrophic gastritis
No atrophic gastritis, The OLGA-0 group;OLGA :Operative Link on Gastritis Assessment)
mild-moderate atrophic gastritis
The OLGA I-II group;OLGA :Operative Link on Gastritis Assessment)
severe atrophic gastritis
The OLGA III-IV group;OLGA :Operative Link on Gastritis Assessment)
Diagnostic test: pepsinogen
serum pepsinogen diagnosed gastric cancer and precanceous lesion
gastric cancer
Diagnostic test: pepsinogen
serum pepsinogen diagnosed gastric cancer and precanceous lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum pepsinogen levels for GC and precancerous lesions
Time Frame: 1 year
cutoff values of pepsinogen level for GC and precancerous lesions in different regions in China and in different HP status
1 year
Risk factors for GC
Time Frame: 1 year
the risk factors for GC, according to the logistic regression model
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Changhai Hospital
Zhongshan Hospital Xiamen University
Chinese PLA General Hospital
Sichuan Provincial People's Hospital
Affiliated Hospital of Southwest Medical University
Kunshan Hospital of Traditional Chinese Medicine
Jilin City People's Hospital
No. 924 Hospital of the People's Liberation Army of China
Jingzhou Hospital of Traditional Chinese Medicine

Investigators

  • Principal Investigator: Yi Zhao, Master, 2nd affiliated hospital of Zhejiang University, School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2016

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 6, 2023

Study Registration Dates

First Submitted

July 8, 2021

First Submitted That Met QC Criteria

July 25, 2021

First Posted (Actual)

August 4, 2021

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

July 25, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 研2015-079

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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