Screening and Validation of Serum Protein Biomarkers for Early Diagnosis of Gastric Cancer

Not yet recruiting

• Conditions: Gastric Cancer (Diagnosis)

• Registration Number: NCT07096752
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

This study focuses on the discovery of protein biomarkers for the early diagnosis of gastric cancer and the development of corresponding detection methods. By employing advanced mass spectrometry-based proteomic technologies, the investigators conducted an in-depth analysis of a large cohort of clinical samples to identify specific protein biomarkers capable of accurately distinguishing gastric cancer patients from healthy individuals. The findings from this research are expected to facilitate the development of novel non-invasive or minimally invasive diagnostic approaches, thereby improving early detection, enhancing patient prognosis, and increasing survival rates.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-23
• Study First Submitted QC: 2025-07-30
• Last Update Submitted: 2025-07-30
• Study First Posted: 2025-07-31
• Last Update Posted: 2025-07-31
• Study Start: 2025-08-01
• Primary Completion: 2026-08-31
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic Performance of the Serum Protein Biomarker-Based Model for Gastric Cancer	3 years	Evaluation of the sensitivity and specificity of a diagnostic model constructed using key serum protein biomarkers for the early detection of gastric cancer.

Secondary Outcome Measures

Name	Time	Method
Predictive performance of the serum protein model for response to neoadjuvant therapy in gastric cancer	3 years	Predictive performance of the serum protein model for response to neoadjuvant therapy in gastric cancer, assessed by prediction accuracy and AUC.
Predictive performance of the serum protein model for the progression risk from precancerous gastric lesions to gastric cancer	3 years	Predictive performance of the serum protein model for the progression risk from precancerous gastric lesions to gastric cancer, evaluated by prediction accuracy and area under the ROC curve (AUC).
Prognostic performance of the serum protein model in gastric cancer patients	3 years	Prognostic performance of the serum protein model in gastric cancer patients, measured by prediction accuracy and AUC.