Metabolic biomarkers from blood and tumor tissue for early detection and prognosis of gastric cancer

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

This project will test whether metabolic markers measured in blood and tumor tissue can help detect gastric cancer earlier and predict prognosis and recurrence for adults with gastric adenocarcinoma.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Minimally Invasive Surgery Center (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07076979 on ClinicalTrials.gov

What this trial studies

This is a prospective observational project enrolling treatment‑naive adults with histologically confirmed gastric adenocarcinoma and healthy control volunteers at Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. Researchers will collect peripheral blood and primary tumor tissue and apply metabolomics to build a gastric cancer–specific metabolite database. The study will search for metabolic signatures associated with early diagnosis, prognosis, recurrence and metastasis, then validate candidate biomarkers within the cohort. The goal is to develop a safe, convenient, and sensitive approach to support early screening and prognostic prediction.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with histopathologically confirmed gastric adenocarcinoma who have not received prior anti‑tumor treatment, have ECOG performance status ≤1, and can provide required tumor tissue and peripheral blood samples, as well as consenting healthy adult controls.

Not a fit: Patients who have had prior cancer therapy, have hereditary cancer syndromes, lack adequate tissue or blood samples, have poor performance status (ECOG >1), or have non‑adenocarcinoma gastric tumors are unlikely to benefit.

Why it matters

Potential benefit: If successful, the biomarkers could enable earlier, less invasive detection of gastric cancer and more accurate prediction of recurrence to guide treatment and follow‑up.

How similar studies have performed: Previous metabolomics studies have identified promising metabolic biomarkers for gastric cancer, but few have been validated prospectively in large clinical cohorts and clinical use remains limited.

Eligibility criteria

Inclusion Criteria:

* \*\*Healthy Controls:\*\*

  1. Age \> 18 years;
  2. Signed informed consent and willingness to participate in the project.

\*\*Gastric Cancer:\*\*

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

Exclusion Criteria:

* \*\*Healthy Controls:\*\*

  1. 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);
  2. History of chronic metabolic or inflammatory diseases that are difficult to control, such as hypertension, diabetes, chronic viral hepatitis, and inflammatory bowel disease;
  3. 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;
  4. History of oral or intravenous use of broad-spectrum antibiotics and probiotics within the past month;
  5. Regular use of immunosuppressive drugs within the past 6 months;
  6. Long-term use of other medications that may affect metabolism, such as hormones;
  7. Inability or unwillingness to cooperate with follow-up visits and related examinations;
  8. Inability to eat normally or requiring medications or enemas for bowel movements;
  9. Presence of psychiatric disorders or other severe cardiovascular diseases;
  10. Pregnant, breastfeeding, or planning to become pregnant within the next year;
  11. Currently participating in an interventional clinical study or receiving study treatment that may influence the patient's treatment decision.

\*\*Gastric Cancer:\*\*

1. Currently participating in an interventional clinical study or receiving study treatment that may influence the patient's treatment decision;
2. 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;
3. History of chronic metabolic or inflammatory diseases that are difficult to control, such as hypertension, diabetes, chronic viral hepatitis, and inflammatory bowel disease;
4. Presence of poorly controlled chronic comorbidities that may affect prognosis;
5. Presence of psychiatric disorders or other severe cardiovascular diseases;
6. Pregnant, breastfeeding, or planning to become pregnant within the next year;
7. Long-term use of medications that may affect metabolism, such as hormones, immunosuppressants, antibiotics, etc.;
8. 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.

Where this trial is running

Shanghai

• Ruijin hospital Shanghai Jiaotong University, School of Medicine , Shanghai, Shanghai 200025 — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Jing Sun

Conditions Gastric Cancer; Gastric cancer; Metabolic marker; Prognosis; Early diagnosis