- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06282484
A Study on the Relationship Between Gastric Xanthoma and Gastric Cancer and Precancerous Lesions
February 21, 2024 updated by: Yongquan Shi, Xijing Hospital of Digestive Diseases
To explore the effects of gastric xanthoma on gastric cancer and its precancerous lesions, so as to better prevent the occurrence and development of gastric cancer.
Study Overview
Status
Completed
Detailed Description
This is a large-scale single center case-control study.
Patients were consecutively enrolled and divided into gastric cancer group, gastric precancerous lesions group, and chronic gastritis group, according to histopathological results.Record the location and quantity of gastric xanthoma and situation of Helicobacter pylori infection in each patient.
Study Type
Observational
Enrollment (Actual)
1260
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shaanxi
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Xi'an, Shaanxi, China, 710032
- Xijing Hosipital of Digestive Disease
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing upper gastrointestinal endoscopy at Xijing Hospital
Description
Inclusion Criteria:
- Age range from 18 to 75 years old, regardless of gender;
- Endoscopic/pathological diagnosis: chronic non atrophic gastritis/chronic atrophic gastritis/intestinal metaplasia/dysplasia Hyperplasia/gastric cancer
- Voluntarily sign an informed consent form.
Exclusion Criteria:
- Previously underwent upper gastrointestinal surgery
- Previous diagnosis of malignant tumors
- Individuals who are unable to cooperate with the questionnaire survey due to mental disorders or other reasons
- Those who cannot be observed by endoscopy due to acute upper gastrointestinal bleeding or other reasons
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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chronic gastritis
patients with chronic non-atrophic gastritis and chronic atrophic gastritis according to histopathological results
|
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precancerous lesion
patients with gastric intestinal metaplasia and intraepithelial neoplasia according to histopathological results
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|
gastric cancer
patients with gastric cancer according to histopathological results
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
corelation between the gastric xanthoma and gastric mucosa diseases
Time Frame: up to 6 months
|
we evaluate the corelation between the gastric xanthoma and gastric mucosa diseases according to the histopathological results and the scales the patients finished
|
up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Yongquan Shi, PhD, Xijing Hosipital of Digestive Disease
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2022
Primary Completion (Actual)
June 1, 2023
Study Completion (Actual)
September 29, 2023
Study Registration Dates
First Submitted
February 21, 2024
First Submitted That Met QC Criteria
February 21, 2024
First Posted (Estimated)
February 28, 2024
Study Record Updates
Last Update Posted (Estimated)
February 28, 2024
Last Update Submitted That Met QC Criteria
February 21, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY20232348-C-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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