Nasal Endoscopic Screening and Risk Assessment for Early Gastric Cancer

NCT ID: NCT04989153

Last Updated: 2021-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-05

Study Completion Date

2023-12-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric Cancer Precancerous Lesion Helicobacter Pylori Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

non-atrophic gastritis

No atrophic gastritis, The OLGA-0 group;OLGA :Operative Link on Gastritis Assessment)

No interventions assigned to this group

mild-moderate atrophic gastritis

The OLGA I-II group;OLGA :Operative Link on Gastritis Assessment)

No interventions assigned to this group

severe atrophic gastritis

The OLGA III-IV group;OLGA :Operative Link on Gastritis Assessment)

pepsinogen

Intervention Type DIAGNOSTIC_TEST

serum pepsinogen diagnosed gastric cancer and precanceous lesion

gastric cancer

gastric cancer

pepsinogen

Intervention Type DIAGNOSTIC_TEST

serum pepsinogen diagnosed gastric cancer and precanceous lesion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pepsinogen

serum pepsinogen diagnosed gastric cancer and precanceous lesion

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jilin City People's Hospital

UNKNOWN

Sponsor Role collaborator

No. 924 Hospital of the People's Liberation Army of China

UNKNOWN

Sponsor Role collaborator

Kunshan Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role collaborator

Sichuan Provincial People's Hospital

OTHER

Sponsor Role collaborator

Affiliated Hospital of Southwest Medical University

OTHER

Sponsor Role collaborator

Zhongshan Hospital Xiamen University

OTHER

Sponsor Role collaborator

Jingzhou Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yi Zhao, Master

Role: PRINCIPAL_INVESTIGATOR

2nd affiliated hospital of Zhejiang university, school of medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jilin City People's Hospital

Jilin, Jilin, China

Site Status RECRUITING

Chinese PLA General Hospital

Beijing, , China

Site Status RECRUITING

Sichuan Provincial People's Hospital

Chengdu, , China

Site Status RECRUITING

The First Hospital affiliated to AMU (Southwest Hospital)

Chongqing, , China

Site Status RECRUITING

No. 924 Hospital of the People's Liberation Army of China

Guilin, , China

Site Status RECRUITING

Jingzhou Hospital of Traditional Chinese Medicine

Jingzhou, , China

Site Status RECRUITING

Kunshan Hospital of Traditional Chinese Medicine

Kunshan, , China

Site Status RECRUITING

Shanghai Changhai Hospital

Shanghai, , China

Site Status RECRUITING

Zhongshan Hospital affiliated to Xiamen University

Xiamen, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zhenya Song, Dr.

Role: CONTACT

13600529612

Yuling Tong, Dr.

Role: CONTACT

13758281220

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hongguang Wang

Role: primary

Hong Li

Role: primary

Lirong Gong

Role: primary

Hongbo Wu

Role: primary

Xueqiang He

Role: primary

Yinhu Luo

Role: primary

Hongwei Xu

Role: primary

Dong Wang

Role: primary

Hongzhi Xu

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

研2015-079

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.