Nasal Endoscopic Screening and Risk Assessment for Early Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04989153
• Other study ID #: ?2015-079
• Status: Recruiting
• Start date: March 5, 2016
• Est. completion date: December 6, 2023

Study information

• Verified date: July 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Zhenya Song, Dr.
• Phone: 13600529612
• Email: songzhenya[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 6, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Helicobacter Pylori Infection
• Precancerous Lesion
• Stomach Neoplasms

Intervention

Diagnostic Test:
• pepsinogen
serum pepsinogen diagnosed gastric cancer and precanceous lesion

Locations

Country	Name	City	State
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	Jilin City People's Hospital	Jilin	Jilin
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

Sponsors (10)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Risk factors for GC	the risk factors for GC, according to the logistic regression model	1 year