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

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
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hosipital of Digestive Disease

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:

  1. Age range from 18 to 75 years old, regardless of gender;
  2. Endoscopic/pathological diagnosis: chronic non atrophic gastritis/chronic atrophic gastritis/intestinal metaplasia/dysplasia Hyperplasia/gastric cancer
  3. Voluntarily sign an informed consent form.

Exclusion Criteria:

  1. Previously underwent upper gastrointestinal surgery
  2. Previous diagnosis of malignant tumors
  3. Individuals who are unable to cooperate with the questionnaire survey due to mental disorders or other reasons
  4. 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
chronic gastritis
patients with chronic non-atrophic gastritis and chronic atrophic gastritis according to histopathological results
precancerous lesion
patients with gastric intestinal metaplasia and intraepithelial neoplasia according to histopathological results
gastric cancer
patients with gastric cancer according to histopathological results

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

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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