Clinical trial NCT06702891: Integrative Analysis of Exosome-Mediated Single-Cell Transcriptomics and Proteomics in Gastric Cardia Cancer
Official title: Integrative Analysis of Exosome-Mediated Single-Cell Transcriptomics and Proteomics in Gastric Cardia Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cardia Cancer
Keywords: Gastric Cardia Cancer
Single-Cell RNA Sequencing
Exosomes
Proteomics
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Differential protein
timeFrame: 6 months
Secondary outcomes:
measure: Key miRNA
timeFrame: 10 months
measure: Differential cell subsets
timeFrame: 12 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References: