The Association Between Microplastics and Macrogenomics and Metabolomics in Gastric Cancer

February 28, 2025 updated by: Dong Peng

Identification of Paraneoplastic and Intratumor Microplastics in Gastric Cancer and Their Association Analysis with Macrogenomics and Metabolomics

The aim of this study was to identify and quantify microplastics in blood, stool, and tumor surgical specimens from gastric cancer patients by analyzing the nature, type, and abundance of microplastics using laser direct infrared (LDIR) spectroscopy, scanning electron microscopy (SEM), and pyrolysis-gas chromatography-mass spectrometry (Py-GC/MS). Meanwhile, combining macro-genomic and metabolomic techniques to explore the association between microplastics and host microbiota and metabolic profiles, and to reveal the potential effects of microplastics on gastric cancer incidence and development will provide new insights into the relationship between microplastic contamination and gastric cancer, as well as an important scientific basis for future public health strategies and cancer prevention and control measures.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This This study is planned to collect blood, cancer and paracancer tissues, and stool samples from 20 patients with gastric cancer, 2 gastric cancer tissues (at least 1cm^3 each), 2 gastric paracancer tissues (at least 1cm^3 each), 2 venous bloods (5ml each), and 1 stool (at least 10g each) from each patient. Samples will be collected from December 2024 through November 2025, with an expected total of 140 samples. Sample collection, transportation, and storage are described in IV.2. & 3. Samples will be analyzed for the type, nature, and abundance of microplastics by Laser Direct Infrared Spectroscopy (LDIR), Scanning Electron Microscopy (SEM), and Pyrolysis-Gas Chromatography-Mass Spectrometry (Py-GC/MS), which is expected to detect microplastics such as polyamides, polyethylene terephthalate (PET), and polyvinyl chloride (PVC). At the same time, blood and tissue samples will be metabolomically assayed using NNR-IVD technology and macro-genomic sequencing will be performed to explore potential associations between microplastics and microbiota and metabolic pathways in gastric cancer patients. By analyzing the distribution characteristics of microplastics in gastric cancer patients and their relationship with microbial communities and metabolic pathways, this study will reveal the impact of microplastics on the tumor microenvironment and further understand their role in gastric cancer development and progression.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

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

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • The First Affiliated Hospital of Chongqing Medical University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with colorectal cancer by pathological biopsy were included in the study.

Description

Inclusion Criteria:

  • age ≥18 years old;
  • diagnosed with gastric cancer by pathology before surgery and not receiving chemotherapy, radiotherapy or immunotherapy;
  • no history of other gastrointestinal diseases;
  • complete clinical data and basic information;
  • willing to participate in this study and sign an informed consent form.

Exclusion Criteria:

  • Patients receiving neoadjuvant radiotherapy or chemotherapy;
  • patients with other malignant tumors other than gastric cancer;
  • patients with incomplete or unclear pathological data;
  • individuals who are not willing to participate in the study.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
the gastric cancer group
patients diagnosed with gastric cancer
Diagnostic test: gastric cancer
Patients diagnosed with gastric cancer by pathological biopsy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Types of microplastics in gastric cancerous and paracancerous tissues (categorical measure)
Time Frame: The date of microplastics testing, assessed up to 1 week after surgery.
Polymer types of microplastics in gastric tissues Time Frame: Intraoperative sampling Measuring tool: μ-FTIR spectroscopy Unit: Categorical classification (e.g., polyethylene, polypropylene, etc.)
The date of microplastics testing, assessed up to 1 week after surgery.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physical-chemical properties of microplastics in gastric cancerous and paracancerous tissues (continuous measure)
Time Frame: The date of microplastics testing, assessed up to 1 week after surgery.
Morphological characteristics of microplastics in gastric tissues Time Frame: Intraoperative sampling Measuring tool: Optical microscopy Unit: Size (μm), shape distribution (%)
The date of microplastics testing, assessed up to 1 week after surgery.
Abundance of microplastics in gastric cancerous and paracancerous tissues (count/particles per gram)
Time Frame: The date of microplastics testing, assessed up to 1 week after surgery.
Microplastic abundance in gastric tissues Time Frame: Intraoperative sampling Measuring tool: Gravimetric analysis/particle counting Unit: Particles per gram tissue
The date of microplastics testing, assessed up to 1 week after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dong Peng

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-530-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data sharing is not permitted by the Ethics Committee of the First Affiliated Hospital of Chongqing Medical University.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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