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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07096752
Enrollment
1200
Registered
2025-07-31
Start date
2025-08-01
Completion date
2029-06-30
Last updated
2025-07-31

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

Conditions

Gastric Cancer (Diagnosis)

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.

Interventions

None listed

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
Yes

Inclusion criteria

Gastric cancer patients enrolled in this study must meet all of the following criteria: 1. Male or female, aged ≥18 and ≤95 years. 2. 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. 3. No prior anti-tumor treatment (including radiotherapy, chemotherapy, targeted therapy, or immunotherapy). 4. Availability of complete clinicopathological data and follow-up information. Patients with precancerous gastric lesions must meet all of the following criteria: 1. Male or female, aged ≥18 and ≤95 years. 2. Histopathologically confirmed absence of gastric cancer. 3. Diagnosis consistent with precancerous gastric lesions as defined by the American Society for Gastrointestinal Endoscopy (ASGE, 2015 edition). 4. Availability of complete clinicopathological data and follow-up information. Healthy controls must meet all of the following criteria: 1. Male or female, aged ≥18 and ≤95 years. 2. Histopathologically confirmed absence of gastric cancer. 3. No evidence of precancerous gastric lesions. 4. Availability of complete clinicopathological data and follow-up information.

Exclusion criteria

Patients meeting any of the following conditions will be excluded: 1. History of prior malignancy or cancer treatment. 2. Presence of concurrent malignancies of other types. 3. Inability to tolerate gastroscopy.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic Performance of the Serum Protein Biomarker-Based Model for Gastric Cancer3 yearsEvaluation of the sensitivity and specificity of a diagnostic model constructed using key serum protein biomarkers for the early detection of gastric cancer.

Secondary

MeasureTime frameDescription
Predictive performance of the serum protein model for the progression risk from precancerous gastric lesions to gastric cancer3 yearsPredictive 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 cancer3 yearsPredictive 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 patients3 yearsPrognostic performance of the serum protein model in gastric cancer patients, measured by prediction accuracy and AUC.

Contacts

Primary ContactZhaoqing Tang
tang.zhaoqing@zs-hospital.sh.cn+86 64041990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026