NCT07542652

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Mar 2026Dec 2026

Study Start

First participant enrolled

March 31, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

April 14, 2026

Last Update Submit

April 25, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlation between external exposure levels of microplastics and three pathological stages of gastric mucosal carcinogenesis

    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 Outcomes (2)

  • Analysis of sources of high - risk microplastic exposure

    9 months

  • Synergistic toxicity of microplastics and Helicobacter pylori

    9 months

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients were enrolled from a single center, Xijing Hospital.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 14, 2026

First Posted

April 21, 2026

Study Start

March 31, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations