- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07542652
Association Between Microplastic Exposure and the Pathological Progression of Gastric Carcinogenesis
April 25, 2026 updated by: Yongquan Shi
Association of Microplastic Exposure With Pathological Stages of Gastric Mucosal Carcinogenesis: A Cross-Sectional Study
The objective of this clinical trial is to explore the correlation between the level of microplastic exposure and the risk of gastric mucosal carcinogenesis, and to evaluate the strength of its effect as an independent risk factor.
The main questions it aims to answer include: Does the level of microplastic exposure increase the risk of gastric mucosal carcinogenesis?
Can the correlation between the level of microplastic exposure and gastric mucosal carcinogenesis, as well as the sources of high - risk microplastic exposure, be explored through a questionnaire on external microplastic exposure?
Researchers will complete a design structured questionnaire and ask participants to fill it out carefully and truthfully to determine whether the level of microplastic exposure increases the risk of gastric mucosal carcinogenesis.
Study Overview
Status
Recruiting
Detailed Description
The study will categorize participants into three groups based on endoscopic and/or histopathological findings: chronic non-atrophic gastritis, precancerous lesions, and gastric cancer.
Basic demographic information, *Helicobacter pylori* infection status, and plastic exposure assessment scores will be recorded for each group.
Study Type
Observational
Enrollment (Estimated)
450
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yongquan Shi
- Phone Number: 029-84771515
- Email: shiyquan@fmmu.edu.cn
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710032
- Recruiting
- 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
No
Sampling Method
Non-Probability Sample
Study Population
Patients were enrolled from a single center, Xijing Hospital.
Description
Inclusion Criteria:
- Aged between 18 and 75 years old, gender is not restricted
- Having a clear diagnosis result within the recent three months and being diagnosed with chronic non - atrophic gastritis, precancerous lesions of gastric cancer, or gastric cancer for the first time
- Have clear Helicobacter pylori (Hp) test results
- Be in normal mental state and able to independently complete the questionnaire survey
Exclusion Criteria:
- Patients with a history of malignant tumors in other parts
- Patients who have previously undergone upper gastrointestinal surgery, chemotherapy, or radiotherapy
- Patients with severe diseases of major organs such as the heart, lungs liver, and kidneys
- Patients who are currently receiving psychological intervention or taking psychiatric drugs
- Pregnant or lactating women
- Patients with severe missing clinical data or questionnaire information
- Refusing to sign the informed consent form
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 non-atrophic gastritis
Patients diagnosed with chronic non-atrophic gastritis based on endoscopic and/or histopathological results
|
|
precancerous lesion
Patients with chronic atrophic gastritis, gastric intestinal metaplasia, and gastric intraepithelial neoplasia based on endoscopic and/or histopathological results
|
|
gastric cancer
patients with gastric cancer according to endoscopic and/or histopathological results
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between external exposure levels of microplastics and three pathological stages of gastric mucosal carcinogenesis
Time Frame: 9 months
|
The investigators evaluated the correlation between external exposure to microplastics and the three pathological stages of gastric mucosal carcinogenesis based on the patients' final diagnosis results and the completed questionnaires they filled out.
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analysis of sources of high - risk microplastic exposure
Time Frame: 9 months
|
Analyze the sources of high-risk microplastic exposure by comparing the scores of each item in the questionnaires of the three groups of participants.
|
9 months
|
|
Synergistic toxicity of microplastics and Helicobacter pylori
Time Frame: 9 months
|
Analyze whether microplastics synergistically promote gastric mucosal injury and increase the risk of canceration with Helicobacter pylori through interaction.
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 31, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
April 14, 2026
First Submitted That Met QC Criteria
April 14, 2026
First Posted (Actual)
April 21, 2026
Study Record Updates
Last Update Posted (Actual)
April 30, 2026
Last Update Submitted That Met QC Criteria
April 25, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY20262104-F-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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