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NCT Number: NCT07076979

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin hospital Shanghai Jiaotong University, School of Medicine , Shanghai, Shanghai 200025

Shanghai, China

Location status: Recruiting

Location contact

Jing Sun, MD, Ph.D

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • **Healthy Controls:**
  • Age > 18 years;
  • Signed informed consent and willingness to participate in the project.

**Gastric Cancer:**

  • Age ≥ 18 years;
  • Performance status (ECOG) score ≤ 1;
  • Histopathologically confirmed gastric adenocarcinoma;
  • No family history of hereditary cancer;
  • No prior anti-tumor treatment;
  • Availability of primary tumor tissue from surgery or biopsy that meets submission requirements;
  • Availability of peripheral blood samples that meet submission requirements;
  • Willingness and ability to sign the informed consent form to participate in the study.

Exclusion criteria

  • **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;
  • History of oral or intravenous use of broad-spectrum antibiotics and probiotics within the past month;
  • Regular use of immunosuppressive drugs within the past 6 months;
  • Long-term use of other medications that may affect metabolism, such as hormones;
  • Inability or unwillingness to cooperate with follow-up visits and related examinations;
  • Inability to eat normally or requiring medications or enemas for bowel movements;
  • Presence of psychiatric disorders or other severe cardiovascular diseases;
  • Pregnant, breastfeeding, or planning to become pregnant within the next year;
  • Currently participating in an interventional clinical study or receiving study treatment that may influence the patient's treatment decision.

**Gastric Cancer:**

  • Currently participating in an interventional clinical study or receiving study treatment that may influence the patient's treatment decision;
  • 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;
  • History of chronic metabolic or inflammatory diseases that are difficult to control, such as hypertension, diabetes, chronic viral hepatitis, and inflammatory bowel disease;
  • Presence of poorly controlled chronic comorbidities that may affect prognosis;
  • Presence of psychiatric disorders or other severe cardiovascular diseases;
  • Pregnant, breastfeeding, or planning to become pregnant within the next year;
  • Long-term use of medications that may affect metabolism, such as hormones, immunosuppressants, antibiotics, etc.;
  • Any severe and/or uncontrolled medical conditions, as judged by the investigator, that may affect the patient's ability to participate in the study or interfere with study results.

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: 3 years

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

  2. Disease-Free Survival

    Time frame: 3 years

    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

  1. Hazard Ratio

    Time frame: 3 years

    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.

  2. Positive Predictive Value

    Time frame: 3 years

    The Positive Predictive Value (PPV) indicates how likely it is that a person actually has the disease if the test result is positive.

  3. Negative Predictive Value

    Time frame: 3 years

    The Negative Predictive Value (NPV) indicates how likely it is that a person does not have the disease if the test result is negative.

  4. Assessment of Important Metabolic Biomarkers

    Time frame: 3 years

    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.

  5. Recurrence Rate

    Time frame: 3 years

  6. Cancer-Related Mortality

    Time frame: 3 years

  7. Time to Recurrence and Metastasis and Specific Sites

    Time frame: 3 years

  8. Distant Metastasis Rate

    Time frame: 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shanghai Minimally Invasive Surgery Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Jul 22, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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