The Effect of Environmental Factors on Gastric Cancer Based on Macrogenome

NCT06854146 | Active Not Recruiting DMC

• 1 other identifier: 2024-444-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Cancers; Air Pollution

Keywords

Gastric Cancer; Macrogenome; Environmental Pollution; Air Pollution

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  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 Outcomes (1)

• Gut microbiome composition differences assessed by shotgun metagenomic sequencing

  Tissue samples collected intraoperatively, sequencing completed within 1 week post-surgery.

Study Arms (2)

gastric cancer group

patients diagnosed with gastric cancer

Diagnostic Test: gastric cancer

control group

healthy participants

Diagnostic Test: healthy

Interventions

gastric cancer DIAGNOSTIC_TEST

patients diagnosed with gastric cancer

gastric cancer group

healthy DIAGNOSTIC_TEST

healthy participants

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dong Peng: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

stool and serum

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

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: February 25, 2025
• First Posted: March 3, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)