NCT06641700

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
42mo left

Started Oct 2024

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Oct 2024Oct 2029

Study Start

First participant enrolled

October 1, 2024

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

October 13, 2024

Last Update Submit

October 14, 2024

Conditions

Keywords

gastric cancerenvironmentair pollutionmetabolomicsgut microorganisms

Outcome Measures

Primary Outcomes (1)

  • Rate of postoperative complications

    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 Outcomes (1)

  • Overall survival

    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

Study Arms (2)

the gastric cancer group

Pre-operative gastric cancer diagnosed by pathological biopsy in our clinic.

Diagnostic Test: diagnosed with gastric cancer

the contol group

Adults with no history of malignancy and willing to participate in this study.

Interventions

Pathological biopsy confirmed the diagnosis of gastric cancer.

the gastric cancer group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

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

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

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

Study Record Dates

First Submitted

October 13, 2024

First Posted

October 15, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2029

Last Updated

October 16, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations