The Effect of Environmental Factors on Gastric Cancer Based on Macrogenome

February 28, 2025 updated by: Dong Peng

Study on the Development and Prognosis of Gastric Cancer Based on Environmental Factors and Macrogenome

The objectives of this study were to clarify how environmental factors such as air pollution affect the occurrence and development of gastric cancer; to identify patient-specific macrogenomic markers of gastric cancer; and to investigate the mechanism of gastric cancer development based on environmental factors and macrogenomic data.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with preoperative diagnosis of gastric cancer confirmed by pathologic biopsy and 1:1 participants with no history of malignancy were included in the study.

Description

Inclusion Criteria:

  • age ≥ 18 years;
  • patients with preoperative diagnosis of gastric cancer confirmed by pathologic biopsy;
  • no chemotherapy, radiotherapy, targeted and immunotherapy, etc. before enrollment;
  • willing to participate in the study and sign the informed consent form;
  • complete clinical data.

Exclusion Criteria:

  • concurrent primary malignant tumor other than gastric cancer;
  • patients with systemic diseases, such as severe cardiopulmonary;
  • insufficiency, that affect the choice of treatment plan;
  • not suitable for enrollment as assessed by the investigator;
  • incomplete clinical data.

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
gastric cancer group
patients diagnosed with gastric cancer
Diagnostic test: gastric cancer
patients diagnosed with gastric cancer
control group
healthy participants
Diagnostic test: healthy
healthy participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From date of diagnosis until the date of death from any cause or or loss to follow-up, whichever came first, assessed up to 60 months

Description: Time from diagnosis to death from any cause, measured via medical records and follow-up interviews.

Unit: Months
From date of diagnosis until the date of death from any cause or or loss to follow-up, whichever came first, assessed up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut microbiome composition differences assessed by shotgun metagenomic sequencing
Time Frame: Tissue samples collected intraoperatively, sequencing completed within 1 week post-surgery.

Measuring Tool: Shotgun metagenomic sequencing (Illumina NovaSeq 6000). Analysis Parameters: Alpha diversity (Shannon index); Beta diversity (Bray-Curtis dissimilarity); Differential abundance of bacterial species (ANCOM-BC).

Unit: Relative abundance (%) / Diversity indices.
Tissue samples collected intraoperatively, sequencing completed within 1 week post-surgery.

Collaborators and Investigators

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

Sponsor

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)

November 1, 2024

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-444-01

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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