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Status unknownNCT03597672SIGES-01Updated Jul 24, 2018

Early Detection and Screening Strategy of Gatric Cancer in Sichuan Province-A Prospective Cohort Study (WCH-GC-SIGES-01)

An observational study in Neoplasm, Stomach, H. Pylori Infection and Chronic Atrophic Gastritis, sponsored by Jian-Kun Hu. Status unknown at 1 site in China. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-24.

Sponsored by Jian-Kun Hu · Observational

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30,000
Ages
20 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

H. pylori was one of the most important carcinogenic factor for gastric cancer and play a crucial role in inducing gastritis, atrophy and canceration. Chronic atrophic gastritis (CAG) was a common precancerous disease, people with CAG become high-risk population and need regular follow-up. However, study about occurrence risk prediction for gastric cancer when H. pylori infection concurrence with CAG was still spare. In especial, there was still no population screening program based on serology. The relative clinical epidemiology for providing evidence for China gastric cancer screening program was very rare.

This study aim to evaluate gastric cancer occurrence risk and diagnostic value of people combined with H. pylori infection and CAG by Serological methods in Sichuan province China. We also project to design optimized screening program suitable for people in sichuan province China.

02

Conditions studied

  • Neoplasm, Stomach
  • H. Pylori Infection
  • Chronic Atrophic Gastritis

Keywords

  • Gastric carcinoma
  • Early diagnosis
  • screening stragety
  • health population cohort
03

In context

Stomach Neoplasms

2,850 studies on the registry are indexed under Stomach Neoplasms; 863 are open to participants now.

This study's planned enrollment of 30,000 is above the median of 274 across 670 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Jian-Kun Hu is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. With history of malignant tumor;
  2. Refuse to donate blood specimen;
  3. With serious comorbidity and/or finite life (less than 5 years);
  4. Request to retreat from this study;
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. The number of new cases of gastric carcinoma

    The new cases of gastric and other epidermal malignant tumor

    Time frame: 5 years

Secondary outcomes

  1. Time of finding nee cases

    The time during SIGES when finding nee gastric cancer and relative disease

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Jian-Kun Hu
    Chengdu, Sichuan 610041, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — pending

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03597672
Lead sponsor
Jian-Kun Hu
Collaborators
Xin-Zu Chen
Responsible party
Jian-Kun Hu (Vice director of Gastrointestinal Surgery department, West China Hospital; Director of Institute of Gastric Cancer, State Key Laboratory of Biotherapy, West China Hospital, West China Hospital) — Sponsor-investigator
First posted
Jul 24, 2018
Start date
Jan 1, 2017
Primary completion
Dec 31, 2019 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Jul 24, 2018

Study contacts

Jian-Kun Hu, M.D. Ph.D.
Contact
hujkwch@126.com
02885422878

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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