Gastric CancersNCT06856382
The Association Between Microplastics and Macrogenomics and Metabolomics in Gastric Cancer
An observational study of Gastric Cancers, run by Dong Peng at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancers
- What is being tested?
- gastric cancer
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with colorectal cancer by pathological biopsy were included in the study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastric Cancers
- Being tested
- gastric cancer
- Keywords
- Gastric cancer, Microplastics, Macrogenomic, Metabolomics, Microenvironment
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric cancerDiagnostic test
Patients diagnosed with gastric cancer by pathological biopsy.
| Study group | Role | What they receive |
|---|---|---|
| the gastric cancer group | patients diagnosed with gastric cancer Receives: Diagnostic Test: gastric cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Types of microplastics in gastric cancerous and paracancerous tissues (categorical measure)
Polymer types of microplastics in gastric tissues Time Frame: Intraoperative sampling Measuring tool: μ-FTIR spectroscopy Unit: Categorical classification (e.g., polyethylene, polypropylene, etc.)
Measured: The date of microplastics testing, assessed up to 1 week after surgery.
Secondary outcomes (2)
Physical-chemical properties of microplastics in gastric cancerous and paracancerous tissues (continuous measure)
Morphological characteristics of microplastics in gastric tissues Time Frame: Intraoperative sampling Measuring tool: Optical microscopy Unit: Size (μm), shape distribution (%)
Measured: 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)
Microplastic abundance in gastric tissues Time Frame: Intraoperative sampling Measuring tool: Gravimetric analysis/particle counting Unit: Particles per gram tissue
Measured: The date of microplastics testing, assessed up to 1 week after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start1 Dec 2024
- 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 CancersStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong Peng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dong Peng, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856382
- Sponsor's protocol ID
- 2024-530-01
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing is not permitted by the Ethics Committee of the First Affiliated Hospital of Chongqing Medical University.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Paraneoplastic and Intratumor Microplastics in Gastric Cancer and Their Association Analysis With Macrogenomics and Metabolomics
- ClinicalTrials.gov ID
- NCT06856382
- Acronym / sponsor ID
- 2024-530-01
- Conditions
- Gastric Cancers
- Keywords
- Gastric cancer, Microplastics, Macrogenomic, Metabolomics, Microenvironment
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Dong PengUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Mar 2025 (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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the gastric cancer group | – | Diagnostic Test: gastric cancerpatients diagnosed with gastric cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with colorectal cancer by pathological biopsy were included in the study.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gastric cancerPatients diagnosed with gastric cancer by pathological biopsy. | Diagnostic test | the gastric cancer group |
Primary outcome
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.)
2 secondary outcomes
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.
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.
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 4 Mar 2025.
- Individual participant dataSharing planned: No. Data sharing is not permitted by the Ethics Committee of the First Affiliated Hospital of Chongqing Medical University.
Related trials for Gastric Cancers
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Cancers, run by Dong Peng 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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 4 Mar 2025.