Exploring the Difference Between Gastric Cardia Cancer and Non-cardia Gastric Cancer Based on Multiomics

Stomach Neoplasm Clinical Trial

Official title:

Exploring the Difference Between Gastric Cardia Cancer and Non-cardia Gastric Cancer Based on Multiomics

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05812287
• Other study ID #: 2023SDU-QILU-2
• Status: Not yet recruiting
• Start date: December 2023
• Est. completion date: December 2028

Study information

• Verified date: March 2023
• Source: Qilu Hospital of Shandong University
• Contact: Miaomiao Ma, Bachelor
• Phone: (86)17657686098
• Email: mmiao6098[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 saliva, serum, and feces from the study subjects. We combined 16S rRNA sequencing and metabolomics to explore the differences in microbial and metabolic characteristics between gastric cardia cancer and non-cardia gastric cancer for early screening of gastric cancer.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Study population signing informed consent form
• Age: 18-75 years old
• 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.

Related Conditions & MeSH terms

• Stomach Neoplasm
• Stomach Neoplasms

Intervention

Other:
• Detection of biological samples based on multi-omics analysis
In this study, we combined microbiological (16SrRNA) and metabolomic mass spectrometry to study the changes in microbial populations and metabolic profiles of various samples such as feces, serum, and saliva, and screen key differential markers.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early gastric cancer detection rate	This study combines 16SrRNA sequencing and metabolomics to explore the differences in microbiota and metabolites between tumor cohorts and healthy controls, and to assist in screening for early gastric cancer.	36 months