NCT03597672

Brief Summary

To establish prospective cohort of healthy population and corresponding serum sample bank in Sichuan province to provide platform for exploring early diagnosis and screening strategy of gastric cancer by a prospective cohort study.

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
30,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 24, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

3 years

First QC Date

July 15, 2018

Last Update Submit

July 15, 2018

Conditions

Keywords

Gastric carcinomaEarly diagnosisscreening stragetyhealth population cohort

Outcome Measures

Primary Outcomes (1)

  • The number of new cases of gastric carcinoma

    The new cases of gastric and other epidermal malignant tumor

    5 years

Secondary Outcomes (1)

  • Time of finding nee cases

    5 years

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In our study, the poplatiion was enrolled among health inhabitant in Sichuan province in China. People who underwent physical examination in our center who statisfy our indications will be introdeced to participate in our study. The informed consent will be endosed and the blood sample will be collected.

You may qualify if:

  • Inhabitant in Sichuan province in China (length of residence \> 10 years);
  • Complete physical examination in our hospital, the outcomes was asymptomatic and cancer free healthy individuals;
  • Age between 20 and 70;
  • With normal cognitive and communication ability;
  • Without gastroscopy during recruitment, physical examination item including gastroscopy enrolled in prospective cohort study;
  • Wiling to accept 1-2 times routine physical examination in our hospital;
  • Agree to accept the follow-up of our project group;

You may not qualify if:

  • With history of malignant tumor;
  • Refuse to donate blood specimen;
  • With serious comorbidity and/or finite life (less than 5 years);
  • Request to retreat from this study;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jian-Kun Hu

Chengdu, Sichuan, 610041, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples

MeSH Terms

Conditions

Stomach NeoplasmsGastritis, AtrophicDisease

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesGastritisGastroenteritisPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Jian-Kun Hu, M.D. Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice director of Gastrointestinal Surgery department, West China Hospital; Director of Institute of Gastric Cancer, State Key Laboratory of Biotherapy, West China Hospital

Study Record Dates

First Submitted

July 15, 2018

First Posted

July 24, 2018

Study Start

January 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2020

Last Updated

July 24, 2018

Record last verified: 2018-07

Locations