Nasal Endoscopic Screening and Risk Assessment for Early Gastric Cancer

• Conditions: Gastric Cancer; Helicobacter Pylori Infection; Precancerous Lesion
• Interventions: Diagnostic Test: pepsinogen

• Registration Number: NCT04989153
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

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 Timeline

• Study Start: 2016-03-05
• Status Verified: 2021-07
• Study First Submitted: 2021-07-08
• Study First Submitted QC: 2021-07-25
• Last Update Submitted: 2021-07-25
• Study First Posted: 2021-08-04
• Last Update Posted: 2021-08-04
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
severe atrophic gastritis	pepsinogen	The OLGA III-IV group;OLGA :Operative Link on Gastritis Assessment)
gastric cancer	pepsinogen	gastric cancer

Primary Outcome Measures

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

Trial Locations

Locations (9)

No. 924 Hospital of the People's Liberation Army of China; 🇨🇳 Guilin, China

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, China

Jingzhou Hospital of Traditional Chinese Medicine; 🇨🇳 Jingzhou, China

Shanghai Changhai Hospital; 🇨🇳 Shanghai, China

Zhongshan Hospital affiliated to Xiamen University; 🇨🇳 Xiamen, China

Jilin City People's Hospital; 🇨🇳 Jilin, Jilin, China

Chinese PLA General Hospital; 🇨🇳 Beijing, China

The First Hospital affiliated to AMU (Southwest Hospital); 🇨🇳 Chongqing, China

Kunshan Hospital of Traditional Chinese Medicine; 🇨🇳 Kunshan, China