Gastric CarcinomaNCT07542652
Association Between Microplastic Exposure and the Pathological Progression of Gastric Carcinogenesis
An observational study of Gastric Carcinoma and Gastritis Chronic, run by Yongquan Shi at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Carcinoma, Gastritis Chronic, Intestinal Metaplasia
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were enrolled from a single center, Xijing Hospital.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, 710032
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (2)
Analysis of sources of high - risk microplastic exposure
Analyze the sources of high-risk microplastic exposure by comparing the scores of each item in the questionnaires of the three groups of participants.
Measured: 9 months
Synergistic toxicity of microplastics and Helicobacter pylori
Analyze whether microplastics synergistically promote gastric mucosal injury and increase the risk of canceration with Helicobacter pylori through interaction.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start31 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CarcinomaStudies 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
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yongquan Shi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongquan Shi, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542652
- Sponsor's protocol ID
- KY20262104-F-1
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 30 Apr 2026
- 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 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Microplastic Exposure With Pathological Stages of Gastric Mucosal Carcinogenesis: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07542652
- Acronym / sponsor ID
- KY20262104-F-1
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Yongquan ShiUniversity, hospital or other
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Apr 2026 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were enrolled from a single center, Xijing Hospital.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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
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.
2 secondary outcomes
Analysis of sources of high - risk microplastic exposure
Time frame: 9 months
Synergistic toxicity of microplastics and Helicobacter pylori
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- 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.
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 Gastric Carcinoma and Gastritis Chronic, run by Yongquan Shi 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 30 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongquan Shi (029-84771515, shiyquan@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between external exposure levels of microplastics and three pathological stages of gastric mucosal carcinogenesis (time frame: 9 months). 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 30 Apr 2026.