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

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.

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Key information

Conditions

Gastric Cancer (Diagnosis) Digestive System Diseases Digestive System Neoplasms Disease Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Stomach Diseases Stomach Neoplasms

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Gastric cancer patients enrolled in this study must meet all of the following criteria:

Male or female, aged ≥18 and ≤95 years.
Histopathologically confirmed gastric cancer, as defined by the 2024 edition of the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Gastric Cancer.
No prior anti-tumor treatment (including radiotherapy, chemotherapy, targeted therapy, or immunotherapy).
Availability of complete clinicopathological data and follow-up information.

Patients with precancerous gastric lesions must meet all of the following criteria:

Male or female, aged ≥18 and ≤95 years.
Histopathologically confirmed absence of gastric cancer.
Diagnosis consistent with precancerous gastric lesions as defined by the American Society for Gastrointestinal Endoscopy (ASGE, 2015 edition).
Availability of complete clinicopathological data and follow-up information.

Healthy controls must meet all of the following criteria:

Male or female, aged ≥18 and ≤95 years.
Histopathologically confirmed absence of gastric cancer.
No evidence of precancerous gastric lesions.
Availability of complete clinicopathological data and follow-up information.

Exclusion criteria

Patients meeting any of the following conditions will be excluded:

History of prior malignancy or cancer treatment.
Presence of concurrent malignancies of other types.
Inability to tolerate gastroscopy.

Treatment and study plan

Primary outcomes

Diagnostic Performance of the Serum Protein Biomarker-Based Model for Gastric Cancer

Time frame: 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 outcomes

Predictive performance of the serum protein model for the progression risk from precancerous gastric lesions to gastric cancer

Time frame: 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).
Predictive performance of the serum protein model for response to neoadjuvant therapy in gastric cancer

Time frame: 3 years

Predictive performance of the serum protein model for response to neoadjuvant therapy in gastric cancer, assessed by prediction accuracy and AUC.
Prognostic performance of the serum protein model in gastric cancer patients

Time frame: 3 years

Prognostic performance of the serum protein model in gastric cancer patients, measured by prediction accuracy and AUC.

Study contacts

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

Zhaoqing Tang

CONTACT

[email protected]

+86 64041990

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2029
First posted: Jul 31, 2025
Registry last updated: Jul 31, 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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