- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06856382
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
Active, not recruiting
Conditions
Intervention / Treatment
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
Observational
Enrollment (Estimated)
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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
the gastric cancer group
patients diagnosed with gastric cancer
|
Patients diagnosed with gastric cancer by pathological biopsy.
|
What is the study measuring?
Primary Outcome Measures
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
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
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)
December 1, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
February 25, 2025
First Submitted That Met QC Criteria
February 28, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 28, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Gastric Cancers
-
Xiangdong ChengRecruitingGastric Cancers | Esophagogastric Junction CancersChina
-
Duke UniversityCompletedLocally Advanced Esophageal and Gastric Cancers (EGC)United States
-
Nanfang Hospital, Southern Medical UniversityRecruiting
-
The First Affiliated Hospital with Nanjing Medical...The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical... and other collaboratorsRecruitingGastric CancersChina
-
Dong PengActive, not recruiting
-
Jichao QinSecond Affiliated Hospital, School of Medicine, Zhejiang University; Jinhua... and other collaboratorsActive, not recruiting
-
First Affiliated Hospital of Chongqing Medical...Completed
-
Dong PengActive, not recruitingAir Pollution | Gastric CancersChina
-
Jules Bordet InstituteCompletedMetastatic Colorectal Cancers | Metastatic Gastric Cancers | Metastatic Oesophageal Cancers | Metastatic Pancreatic Cancers | Metastatic Biliary Cancers | Metastatic Breast CancersBelgium
-
National Health Research Institutes, TaiwanNational Taiwan University Hospital; National Cheng-Kung University HospitalCompletedGastric Cancer in Situ | Pancreatic Cancers | Biliary CancersTaiwan
Clinical Trials on gastric cancer
-
Beijing Friendship HospitalRecruitingGastric Cancer | Esophagus CancerChina
-
First Affiliated Hospital of Chongqing Medical...Completed
-
Beijing Friendship HospitalCompleted
-
Adana City Training and Research HospitalCompletedStomach Cancer | Corona Virus InfectionTurkey
-
Cantonal Hospital of St. GallenCompletedGastric CancerSwitzerland
-
Dong PengActive, not recruitingAir Pollution | Gastric CancersChina
-
West China HospitalUnknown
-
Dong PengActive, not recruiting
-
Karadeniz Technical UniversityCompleted