NCT06856382

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Dec 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress69%
Dec 2024Dec 2026

Study Start

First participant enrolled

December 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2025

Completed
1.8 years 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

March 4, 2025

Status Verified

February 1, 2025

Enrollment Period

2.1 years

First QC Date

February 25, 2025

Last Update Submit

February 28, 2025

Conditions

Keywords

Gastric cancerMicroplasticsMacrogenomicMetabolomicsMicroenvironment

Outcome Measures

Primary Outcomes (1)

  • 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.)

    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)

    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)

    The date of microplastics testing, assessed up to 1 week after surgery.

Study Arms (1)

the gastric cancer group

patients diagnosed with gastric cancer

Diagnostic Test: gastric cancer

Interventions

gastric cancerDIAGNOSTIC_TEST

Patients diagnosed with gastric cancer by pathological biopsy.

the gastric cancer group

Eligibility Criteria

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

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

surgically resected tissue and serum

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 4, 2025

Study Start

December 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 4, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

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

Locations