About this trial
This prospective clinical observational study aims to construct a metabolite database specifically for gastric cancer patients using metabolomics technology. It seeks to develop and validate metabolic biomarkers for early diagnosis, prognosis, and prediction of recurrence and metastasis in gastric cancer, thereby a establishing safe, convenient, and highly sensitive method for early screening and prognostic prediction.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
**Healthy Controls:**
Age > 18 years;
Signed informed consent and willingness to participate in the project.
Age ≥ 18 years;
Disqualifiers
**Healthy Controls:**
Individuals at high risk for hereditary colorectal adenocarcinoma, including family members of the following diseases: family history of gastrointestinal tumors, familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC/LS), and Peutz-Jeghers syndrome (P-J syndrome);
History of chronic metabolic or inflammatory diseases that are difficult to control, such as hypertension, diabetes, chronic viral hepatitis, and inflammatory bowel disease;
Known history of other malignancies that have progressed or required treatment within the past 5 years, except for skin basal cell carcinoma and squamous cell carcinoma that have been cured;
Trial population
Patients with gastric cancer and healthy individuals.
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Overall survival
The time from the start of treatment to death due to any cause.
Disease-Free Survival
Disease-Free Survival (DFS) refers to the length of time after primary treatment for a disease during which the patient remains free of certain signs or symptoms of the disease. It is typically measured from the start of treatment until the first recurrence or relapse of the disease.
Secondary outcomes
Hazard Ratio
The hazard ratio is a measure of the relative risk of an event occurring in one group compared to another group. It is used to quantify the difference in the rate at which events occur between two groups, typically a treatment group and a control group.
Positive Predictive Value
The Positive Predictive Value (PPV) indicates how likely it is that a person actually has the disease if the test result is positive.
Negative Predictive Value
The Negative Predictive Value (NPV) indicates how likely it is that a person does not have the disease if the test result is negative.
Assessment of Important Metabolic Biomarkers
This outcome measure is intended to identify important metabolic biomarkers that are highly statistically associated with the prognosis of gastric cancer, such as OS, DFS, etc., given different time frames.
Sponsors and contacts
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