Integrative Analysis of Exosome-Mediated Single-Cell Transcriptomics and Proteomics in Gastric Cardia Cancer

This is an observational study with a case control design. This study included patients with gastric cancer confirmed by pathological diagnosis of gastric tissue, and matched the control population according to age, gender, etc. In this study, researchers collected clinical information and multiple biological samples such as serum and tissue tissue from the study subjects. The researchers combined exosome sequencing, proteomics and single-cell RNA sequencing to explore the heterogeneity of cardia cancer, identify specific biomarkers and potential therapeutic targets for cardia cancer, and provide a basis for the development of new diagnostic tools and therapeutic strategies.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cardia Cancer
• Intervention / Treatment: Other: Detection of biological samples based on exosome sequencing, proteomics and single-cell RNA sequencing

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Xiaoya Wang, Bachelor; Phone Number: (86)13821379210; Email: xiaoyawang99@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: Email: xiaoyawang99@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Case:

The population in the case group signed an informed consent form, aged 18 years old or older. All subjects underwent endoscopic examination and were confirmed by pathological diagnosis as gastric cancer, including high-grade intraepithelial neoplasia, early gastric cancer, and advanced gastric cancer.

Control:

The age and gender of the study subjects in the control group were matched to the study population in the case group. The pathological results of the stomach of all subjects showed no malignant changes, including normal gastric mucosa, superficial gastritis, non atrophic gastritis, and gastric polyps, etc.

Description

Inclusion Criteria:

• Study population signing informed consent form
• Age: 18 years old or older
• The study population must underwent endoscopic examination and was confirmed by pathological diagnosis as gastric cancer: including high-level intraepithelial neoplasia, early gastric cancer, and advanced gastric cancer.

Exclusion Criteria:

• Those who have undergone gastrointestinal surgery within the past 1 year; Patients who have undergone neoadjuvant chemotherapy and have developed tumors in the residual stomach after previous partial gastrectomy.
• Those who have used proton pump inhibitors, antibiotics, probiotics, and prebiotics daily within the past month, and those who have recently received hormone therapy.
• People with infectious diseases and other digestive system diseases that interfere with the experimental results, such as inflammatory bowel disease, irritable bowel syndrome, etc.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
case group; The case group includes high-grade intraepithelial neoplasia of the stomach, early gastric cancer, and advanced gastric cancer.	Other: Detection of biological samples based on exosome sequencing, proteomics and single-cell RNA sequencing; The researchers combined exosome sequencing, proteomics and single-cell RNA sequencing to explore the heterogeneity of cardia cancer, identify specific biomarkers and potential therapeutic targets for cardia cancer.
control group; Pathological findings in the control group showed no malignant changes in the stomach, including normal gastric mucosa, superficial gastritis, non atrophic gastritis, and gastric polyps, etc.	Other: Detection of biological samples based on exosome sequencing, proteomics and single-cell RNA sequencing; The researchers combined exosome sequencing, proteomics and single-cell RNA sequencing to explore the heterogeneity of cardia cancer, identify specific biomarkers and potential therapeutic targets for cardia cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Differential protein	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Key miRNA		10 months
Differential cell subsets	Differential cell subsets between cardiac cancer tissue and normal tissue	12 months

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Proteomics; Exosomes; Gastric Cardia Cancer; Single-Cell RNA Sequencing
• Other Study ID Numbers: 2024SDU-QILU-2

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