Nasal Endoscopic Screening and Risk Assessment for Early Gastric Cancer
China Health Promotion Foundation/the Second Affiliated Hospital of Zhejiang University, School of Medicine
1 other identifier
observational
5,000
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2016
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 5, 2016
CompletedFirst Submitted
Initial submission to the registry
July 8, 2021
CompletedFirst Posted
Study publicly available on registry
August 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 6, 2023
CompletedAugust 4, 2021
July 1, 2021
6.8 years
July 8, 2021
July 25, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
serum pepsinogen levels for GC and precancerous lesions
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
the risk factors for GC, according to the logistic regression model
1 year
Study Arms (4)
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)
gastric cancer
gastric cancer
Interventions
serum pepsinogen diagnosed gastric cancer and precanceous lesion
Eligibility Criteria
consecutive subjects who underwent regular health checkup at nine International Healthcare Centers in different regions of China
You may qualify if:
- intention to undergo gastroscopy during health checkup examination 25-75 years of age.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang Universitylead
- Jilin City People's Hospitalcollaborator
- No. 924 Hospital of the People's Liberation Army of Chinacollaborator
- Kunshan Hospital of Traditional Chinese Medicinecollaborator
- Chinese PLA General Hospitalcollaborator
- Sichuan Provincial People's Hospitalcollaborator
- Affiliated Hospital of Southwest Medical Universitycollaborator
- Zhongshan Hospital Xiamen Universitycollaborator
- Jingzhou Hospital of Traditional Chinese Medicinecollaborator
- Changhai Hospitalcollaborator
Study Sites (9)
Jilin City People's Hospital
Jilin, Jilin, China
Chinese PLA General Hospital
Beijing, China
Sichuan Provincial People's Hospital
Chengdu, China
The First Hospital affiliated to AMU (Southwest Hospital)
Chongqing, China
No. 924 Hospital of the People's Liberation Army of China
Guilin, China
Jingzhou Hospital of Traditional Chinese Medicine
Jingzhou, China
Kunshan Hospital of Traditional Chinese Medicine
Kunshan, China
Shanghai Changhai Hospital
Shanghai, China
Zhongshan Hospital affiliated to Xiamen University
Xiamen, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yi Zhao, Master
2nd affiliated hospital of Zhejiang university, school of medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2021
First Posted
August 4, 2021
Study Start
March 5, 2016
Primary Completion
December 31, 2022
Study Completion
December 6, 2023
Last Updated
August 4, 2021
Record last verified: 2021-07