Clinical trial NCT04989153: Nasal Endoscopic Screening and Risk Assessment for Early Gastric Cancer
Official title: China Health Promotion Foundation/the Second Affiliated Hospital of Zhejiang University, School of Medicine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Precancerous Lesion
Helicobacter Pylori Infection
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Jilin City People's Hospital
name: No. 924 Hospital of the People's Liberation Army of China
name: Kunshan Hospital of Traditional Chinese Medicine
name: Chinese PLA General Hospital
name: Sichuan Provincial People's Hospital
name: Affiliated Hospital of Southwest Medical University
name: Zhongshan Hospital Xiamen University
name: Jingzhou Hospital of Traditional Chinese Medicine
name: Changhai Hospital
First posted: 2021-08-04
Enrollment: 5000
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive subjects who underwent regular health checkup at nine International Healthcare Centers in different regions of China

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.

Eligibility criteria: 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.

Primary outcomes:
measure: serum pepsinogen levels for GC and precancerous lesions
timeFrame: 1 year
measure: Risk factors for GC
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jilin
country: China
facility: Jilin City People's Hospital
state: Jilin
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: Chongqing
country: China
facility: The First Hospital affiliated to AMU (Southwest Hospital)
city: Guilin
country: China
facility: No. 924 Hospital of the People's Liberation Army of China
city: Jingzhou
country: China
facility: Jingzhou Hospital of Traditional Chinese Medicine
city: Kunshan
country: China
facility: Kunshan Hospital of Traditional Chinese Medicine
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
city: Xiamen
country: China
facility: Zhongshan Hospital affiliated to Xiamen University
Study officials:
affiliation: 2nd affiliated hospital of Zhejiang university, school of medicine
name: Yi Zhao, Master
role: PRINCIPAL_INVESTIGATOR
References: