Early Gastric CancerNCT05291728
Screening for Early Gastric Cancer in Shaanxi Province
An observational study of Early Gastric Cancer, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial summary
This study collect the relevant data of local residents over 20 years old in 11 regions of Shaanxi Province, The basic information of the subjects was collected by filling in the questionnaire, and serum helicobacter pylori antibody detection was completed at the same time. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Early Gastric Cancer
- How many people
- 12,500,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 1 Oct 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will be carried out in 11 regions of Shaanxi Province from October 2020 to October 2026. Data of permanent resident population (registered population combined with floating population) in the region will be obtained by the local government, and all permanent residents over 20 years old in each region will be identified as the target population. It is preliminarily estimated that the permanent residents over 20 years old in each region of Shaanxi account for about 20%-60% of the total population, and the screening target of permanent residents over 20 years old in each region is finally established in this project.
Who may be able to join
- Local resident over 20 years old.
- Obtain verbal informed consent of the subject.
Who cannot join
- Refused to participate in this research project.
- Questionnaires or serological tests for helicobacter pylori antibodies were not completed.
- This study was not completed due to other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second affiliated hospital of xi'an jiaotong university
Xi'an, Shaanxi, 710004
Jinhai Wang, MD, +86-29-13609281113, jinhaiwang@hotmail.com
About this study
This study collect the relevant data of local residents over 20 years old in 11 regions of Shaanxi Province, The basic information of the subjects was collected by filling in the questionnaire, and serum helicobacter pylori antibody detection was completed at the same time. The expert group determined the high-risk population of gastric cancer after comprehensive evaluation. All the high-risk population of gastric cancer without contraindications underwent electronic gastroscopy in the designated hospital after signing the informed consent. By collecting and analyzing data, early gastric cancer screening was completed and a new gastric cancer risk assessment model was established to evaluate the prevalence of dyspepsia, gastroesophageal reflux disease and precancerous lesions in the natural population of Shaanxi Province, as well as helicobacter pylori infection, radical treatment and recurrence rate.
Read the detailed description
From October 2020 to October 2026, after obtaining the informed consent of local residents over 20 years old in 11 regions of Shaanxi Province, the subjects' social demographic characteristics, living and eating habits, and previous diseases were collected by filling in questionnaires, and serum helicobacter pylori antibody was detected at the same time. After comprehensive assessment by the expert group, the high-risk population of gastric cancer was determined. All high-risk population of gastric cancer without contraindications underwent electronic gastroscopy in designated hospitals after signing informed consent. By collecting and analyzing data, early gastric cancer screening was completed and a new gastric cancer risk assessment model was established to evaluate the prevalence of dyspepsia, gastroesophageal reflux disease and precancerous lesions in the natural population of Shaanxi Province, as well as helicobacter pylori infection, radical treatment and recurrence rate. In this project, the research group was responsible for formulating the plan, designing the questionnaire, and conducting quality control and grass-roots guidance tour. Guanghua Science and Technology Foundation provided public welfare assistance, and distributed and collected questionnaires with the assistance of grass-roots clinics. Finally, the research group sorted out and analyzed the data.
- Conditions
- Early Gastric Cancer
- Keywords
- early GC,Hp infection,FD, GERD , precancerous lesions
- Medical subject headings
- Stomach Neoplasms, Gastroesophageal Reflux
What is being measured
The primary outcome is the main question the study is designed to answer.
the detection rate of early gastric cancer
Patients at high risk of gastric cancer were assessed by questionnaire and Hp test results, and then underwent gastroscopy.Then analyse the detection rate of early gastric cancer.
Measured: 2020.10.01-2026.10.01
Secondary outcomes (1)
the prevalence of dyspepsia, gastroesophageal reflux disease and precancerous lesions in the natural population of Shaanxi Province, as well as the prevalence of helicobacter pylori infection, radical treatment and recurrence rate.
Basic information, Hp antibody detection results and gastroscopy results were collected,and then analyse the prevalence of dyspepsia, gastroesophageal reflux disease and precancerous lesions in the natural population of Shaanxi Province, as well as the prevalence of helicobacter pylori infection, radical treatment and recurrence rate.
Measured: 2020.10.01-2026.10.01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start1 Oct 2020
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Gastric CancerStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 12,500,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jinhai Wang, MD, Study director, Second Affilated Hospital of Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291728
- Sponsor's protocol ID
- 2021036
- Status last verified
- Feb 2022
- First submitted
- 24 Feb 2022
- Last updated
- 23 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Early Gastric Cancer in Shaanxi Province
- ClinicalTrials.gov ID
- NCT05291728
- Acronym / sponsor ID
- 2021036
- Conditions
- Early Gastric Cancer
- Keywords
- early GC,Hp infection,FD, GERD , precancerous lesions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12,500,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 23 Mar 2022 (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.
This study collect the relevant data of local residents over 20 years old in 11 regions of Shaanxi Province, The basic information of the subjects was collected by filling in the questionnaire, and serum helicobacter pylori antibody detection was completed at the same time. The expert group determined the high-risk population of gastric cancer after comprehensive evaluation. All the high-risk population of gastric cancer without contraindications underwent electronic gastroscopy in the designated hospital after signing the informed consent. By collecting and analyzing data, early gastric cancer screening was completed and a new gastric cancer risk assessment model was established to evaluate the prevalence of dyspepsia, gastroesophageal reflux disease and precancerous lesions in the natural population of Shaanxi Province, as well as helicobacter pylori infection, radical treatment and recurrence rate.
Detailed description
From October 2020 to October 2026, after obtaining the informed consent of local residents over 20 years old in 11 regions of Shaanxi Province, the subjects' social demographic characteristics, living and eating habits, and previous diseases were collected by filling in questionnaires, and serum helicobacter pylori antibody was detected at the same time. After comprehensive assessment by the expert group, the high-risk population of gastric cancer was determined. All high-risk population of gastric cancer without contraindications underwent electronic gastroscopy in designated hospitals after signing informed consent. By collecting and analyzing data, early gastric cancer screening was completed and a new gastric cancer risk assessment model was established to evaluate the prevalence of dyspepsia, gastroesophageal reflux disease and precancerous lesions in the natural population of Shaanxi Province, as well as helicobacter pylori infection, radical treatment and recurrence rate. In this project, the research group was responsible for formulating the plan, designing the questionnaire, and conducting quality control and grass-roots guidance tour. Guanghua Science and Technology Foundation provided public welfare assistance, and distributed and collected questionnaires with the assistance of grass-roots clinics. Finally, the research group sorted out and analyzed the data.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be carried out in 11 regions of Shaanxi Province from October 2020 to October 2026. Data of permanent resident population (registered population combined with floating population) in the region will be obtained by the local government, and all permanent residents over 20 years old in each region will be identified as the target population. It is preliminarily estimated that the permanent residents over 20 years old in each region of Shaanxi account for about 20%-60% of the total population, and the screening target of permanent residents over 20 years old in each region is finally established in this project.
Key inclusion criteria (2 listed)
- Local resident over 20 years old.
- Obtain verbal informed consent of the subject.
Key exclusion criteria (3 listed)
- Refused to participate in this research project.
- Questionnaires or serological tests for helicobacter pylori antibodies were not completed.
- This study was not completed due to other reasons.
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 detection rate of early gastric cancer
Time frame: 2020.10.01-2026.10.01
Patients at high risk of gastric cancer were assessed by questionnaire and Hp test results, and then underwent gastroscopy.Then analyse the detection rate of early gastric cancer.
1 secondary outcome
the prevalence of dyspepsia, gastroesophageal reflux disease and precancerous lesions in the natural population of Shaanxi Province, as well as the prevalence of helicobacter pylori infection, radical treatment and recurrence rate.
Time frame: 2020.10.01-2026.10.01
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Individual participant dataSharing planned: No
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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.
jinhai Wang, MD study director
Second Affilated Hospital of Xi'an Jiaotong University
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 Early Gastric Cancer, run by Second Affiliated Hospital of Xi'an Jiaotong University 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 2 inclusion and 3 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 23 Mar 2022. 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 jinhai Wang, MD (029-87679335, jinhaiwang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the detection rate of early gastric cancer (time frame: 2020.10.01-2026.10.01). 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 23 Mar 2022.