Predictive Value of Air Pollution and Metabolomics for Gastric Cancer.

October 14, 2024 updated by: Dong Peng

The Development and Prognosis of Gastric Cancer Based on Air Pollution and Metabolomics

As one of the common malignant tumours worldwide, gastric cancer continues to have a high incidence and mortality rate, especially in Asia. Although a large number of studies have focused on its underlying genetic and lifestyle factors, the specific role of environmental factors in gastric cancer development and progression has not been fully elucidated. Air pollution, a growing environmental problem, and its major components such as PM2.5, PM10, and NO2 have been shown to be closely associated with the occurrence and development of many chronic diseases. Recent studies have gradually revealed the association between air pollution and certain cancer types (e.g., lung cancer), but its relationship with gastric cancer remains relatively unexplored. Against this background, the application of metabolomics provides new perspectives and methods to study the association between gastric cancer and environmental factors. Metabolomics is capable of systematically analysing the metabolite composition and changes in individuals under different environmental exposures, revealing the potential effects of environmental factors, such as air pollution, on individual metabolic functions. By combining air pollution data and metabolomics analysis, investigators can deeply explore the role of environmental factors in the occurrence, development and prognosis of gastric cancer, and thus provide a scientific basis for the development of prevention and treatment strategies.

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

In this study, clinical data, blood, urine and stool specimens were collected by including patients in the healthy control group and gastric cancer group. The air pollution indicators, metabolomics determination and macro genomic determination were extracted from clinical data, blood and stool respectively. The extracted air pollution, metabolomics and intestinal microbiota data were integrated and analysed. Based on machine learning, a comprehensive model was constructed to screen the key indicators that play a role in the development of gastric cancer and construct a prediction model for gastric cancer development. The aim of this study is to investigate how environmental, metabolic and microbiota factors affect the occurrence and development of gastric cancer. Secondly, metabolic markers specific to gastric cancer patients can also be identified, providing a basis for early diagnosis, early intervention and individualised treatment.

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.
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

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

All adult patients diagnosed with gastric and undergoing radical surgery for gastric cancer at the study centre may be included in the gastric cancer group.

Description

Inclusion Criteria:

  • Diagnosis of gastric cancer confirmed by pathology or cytology;
  • aged >18 years;
  • not received chemotherapy, radiotherapy, targeted therapy or immunotherapy;
  • post-operative pathological stages other than stage IV, or no liver, lung or other organs as confirmed by CT, MRI, B-ultrasound imaging.

Exclusion Criteria:

  • Patients with systemic diseases such as severe cardiorespiratory insufficiency affecting the choice of treatment regimen;
  • inappropriate for enrolment 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

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
Pre-operative gastric cancer diagnosed by pathological biopsy in our clinic.
Diagnostic test: diagnosed with gastric cancer
Pathological biopsy confirmed the diagnosis of gastric cancer.
the contol group
Adults with no history of malignancy and willing to participate in this study.

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
Rate of postoperative complications
Time Frame: From date of surgery until the date of first documented postoperative complication, assessed up to 2 months after surgery.
Surgical complications was defined as any postoperative complication occurring during the postoperative hospitalisation period.
From date of surgery until the date of first documented postoperative complication, assessed up to 2 months 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
Overall survival
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
Overall survival was defined as time from date of diagnosis until the date of death from any cause or or loss to follow-up.
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

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.
October 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.
October 1, 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.
October 1, 2029

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).
October 13, 2024

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.
October 13, 2024

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.
October 15, 2024

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.
October 16, 2024

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.
October 14, 2024

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.
October 1, 2024

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.
  • 2024-221-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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