Development and Validation of Metabolic Biomarkers for Early Diagnosis, Prognosis, and Recurrence of Gastric Cancer:MetBio-GC

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Minimally Invasive Surgery Center

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 volunteers

Qualifiers

**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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

250 Participants
are grouped into 2 trial groups
Group A: Baseline
Group B: GC

Trial outcomes

Primary outcomes

1

Overall survival

The time from the start of treatment to death due to any cause.

Time frame
3 years
2

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.

Time frame
3 years

Secondary outcomes

1

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.

Time frame
3 years
2

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.

Time frame
3 years
3

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.

Time frame
3 years
4

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.

Time frame
3 years

Other outcomes

Sponsors and contacts

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