Neoplasm, StomachSIGES-01NCT03597672
Early Detection and Screening Strategy of Gatric Cancer in Sichuan Province-A Prospective Cohort Study (WCH-GC-SIGES-01)
An observational study of Neoplasm, Stomach and H. Pylori Infection, run by Jian-Kun Hu at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Neoplasm, Stomach, H. Pylori Infection, Chronic Atrophic Gastritis
- How many people
- 30,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jian-Kun Hu
Chengdu, Sichuan, 610041
Jian-Kun Hu, 02885422878 ext. 02885422878, hujkwch@126.com
About this study
Official title: A Prospective Cohort Study of Early Detection and Screening Strategy for Gatric Cancer in Sichuan Province China (SIGES-01)
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
- 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.
- Keywords
- Gastric carcinoma, Early diagnosis, screening stragety, health population cohort
- Medical subject headings
- Stomach Neoplasms, Gastritis, Atrophic, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of new cases of gastric carcinoma
The new cases of gastric and other epidermal malignant tumor
Measured: 5 years
Secondary outcomes (1)
Time of finding nee cases
The time during SIGES when finding nee gastric cancer and relative disease
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start1 Jan 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm, StomachStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jian-Kun Hu
- Sponsor type
- University, hospital or other
- Collaborators
- Xin-Zu Chen
- Responsible party
- Sponsor-investigator, Jian-Kun Hu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597672
- Sponsor's protocol ID
- WCH-GC-SIGES-01
- Other IDs
- 320.2710.1815
- Acronym
- SIGES-01
- Status last verified
- Jul 2018
- First submitted
- 15 Jul 2018
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: pending
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Early Detection and Screening Strategy for Gatric Cancer in Sichuan Province China (SIGES-01)
- ClinicalTrials.gov ID
- NCT03597672
- Acronym / sponsor ID
- SIGES-01 / WCH-GC-SIGES-01
- Keywords
- Gastric carcinoma, Early diagnosis, screening stragety, health population cohort
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Jian-Kun HuUniversity, hospital or other
- Collaborators
- Xin-Zu Chen
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 24 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of new cases of gastric carcinoma
Time frame: 5 years
The new cases of gastric and other epidermal malignant tumor
1 secondary outcome
Time of finding nee cases
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Individual participant dataSharing planned: Undecided. pending
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasm, Stomach and H. Pylori Infection, run by Jian-Kun Hu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian-Kun Hu, M.D. Ph.D. (02885422878, hujkwch@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of new cases of gastric carcinoma (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.