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Serum N-Glycan Biomarkers-Based Lymph Node Metastasis Prediction Model for Early Gastric Cancer: A Prospective Multicenter Observational Study

Serum N-Glycan Biomarkers-Based Lymph Node Metastasis Prediction Model for Early Gastric Cancer: A Prospective Multicenter Observational Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500108698
Enrollment
Unknown
Registered
2025-09-03
Start date
2025-09-05
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer

Interventions

Observation group:None

Sponsors

Department of General Surgery, Zhongshan Hospital, Fudan University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Voluntarily sign the informed consent form; 2. Age greater than or equal to 18 years old and less than 80 years old; 3. Serum specimens can be collected before surgery, and the quality of the specimens meets the requirements of glycomics analysis. 4. Highly suspected EGC by endoscopic biopsy or imaging evaluation, that is, tumor invasion is limited to the mucosa or submucosa; and subjects who are diagnosed with EGC by surgical specimen within 30 days after blood collection; 5. Proposed radical resection of gastric cancer (D1 or D2 lymph node dissection).

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. History of distant metastasis (stage M1) or other malignant tumors before surgery; 3. Combined with serious systemic diseases (such as severe liver and kidney insufficiency, active cardiovascular disease, etc.); 4. Combined with autoimmune diseases, infectious diseases or inflammatory states (may affect serum glycosylation status); 5. Severe hematological diseases or coagulation dysfunction; 6. Subjects have received any of the following anti-tumor treatments before blood collection: local or systemic chemoradiotherapy, targeted therapy (including anti-angiogenesis), immunotherapy, cancer vaccines, hormone therapy.

Design outcomes

Primary

MeasureTime frame
Lymph Node Metastasis Status;N-glycosylation Analysis Results;

Secondary

MeasureTime frame
Age;Gender;Tumor size;Scope of operation;Mode of operation;

Countries

China

Contacts

Public ContactGao Xiaodong

Department of General Surgery, Zhongshan Hospital, Fudan University School of Medicine

gao.xiaodong1@zs-hospital.sh.cn+86 137 7421 0207

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026