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Trial Title:
Exploring the Difference Between Gastric Cardia Cancer and Non-cardia Gastric Cancer Based on Multiomics
NCT ID:
NCT05812287
Condition:
Stomach Neoplasm
Conditions: Official terms:
Stomach Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
Detection of biological samples based on multi-omics analysis
Description:
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.
Arm group label:
Case
Arm group label:
Control
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.
Criteria for eligibility:
Study pop:
Case:
The population in the case group signed an informed consent form, aged between 18 and 75
years. 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.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
December 2023
Completion date:
December 2028
Lead sponsor:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Source:
Qilu Hospital of Shandong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05812287
