NCT04957407

Brief Summary

Based on the gastric cancer database established earlier, this project explored the PG standard suitable for Chinese people, and further explored the establishment of machine learning model to stratify gastric cancer risk in the population, guide the frequency of gastroscopy screening, and extract important gastric cancer risk factors from it.Establish electronic health records of gastric organs, track the development and outcome of gastric diseases through deep learning method, in order to predict the development and outcome of gastric diseases;Then, the simulation hypothesis deductive method is used to compare the outcomes that may be caused by different lifestyles with the help of deep learning model, so as to guide patients to develop a better lifestyle and explore the establishment of health management paths for gastric cancer patients and high-risk groups in China.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

July 12, 2021

Status Verified

June 1, 2021

Enrollment Period

3.4 years

First QC Date

July 8, 2021

Last Update Submit

July 8, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • pepsinogen value for precanceous lesion and Gastric cancer

    pepsinogen value for precanceous lesion and Gastric cancer

    1 year

Study Arms (4)

non-atrophic gastritis

OLGA-0 group;OLGA (Operative Link on Gastritis Assessment)

mild-moderate atrophic gastritis

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

severe atrophic gastritis

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

Other: pepsinogen

gastric cancer

gastric cancer

Other: pepsinogen

Interventions

diagnostic value of pepsinogen for severe atrophy and gastric cancer

gastric cancersevere atrophic gastritis

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

consecutive subjects who underwent regular health checkup at nine International Healthcare

You may qualify if:

  • ) intention to undergo gastroscopy during health checkup examination; and 2) 25-75 years of age

You may not qualify if:

  • \) a history of gastric ulcer, gastric polyp, or GC; 2) a history of gastrectomy; 3) treatment with a proton pump inhibitor in the last month; 4) contraindications to gastroscopy; 5) a history of Hp eradication; 6) a history of abdominal pain, abdominal distention, belching, acid reflux, nausea and other digestive tract symptoms within 1 month or 67) incomplete data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zhejiang Provincial Hospital of Traditional Chinese Medicine

Hangzhou, China

RECRUITING

Ningbo cadres health center

Ningbo, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Pepsinogen A

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

PepsinogensEnzyme PrecursorsEnzymes and CoenzymesProtein PrecursorsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Yuling Tong, Dr.

    2nd affiliated hospital of Zhejiang University, school of medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuling Tong, Dr.

CONTACT

Yi Zhao, Master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2021

First Posted

July 12, 2021

Study Start

January 1, 2019

Primary Completion

May 31, 2022

Study Completion

December 31, 2022

Last Updated

July 12, 2021

Record last verified: 2021-06

Locations