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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05812287
Other study ID # 2023SDU-QILU-2
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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