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

NCT07096752 | Not Yet Recruiting

• 1 other identifier: B2025-308R
• Study Type: observational
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastric Cancer (Diagnosis)

Outcome Measures

Primary Outcomes (1)

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

  Evaluation of the sensitivity and specificity of a diagnostic model constructed using key serum protein biomarkers for the early detection of gastric cancer.

  3 years

Secondary Outcomes (3)

• 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 response to neoadjuvant therapy in gastric cancer

  3 years

• Prognostic performance of the serum protein model in gastric cancer patients

  3 years

Study Arms (2)

Gastric cancer

Patients with histopathologically confirmed gastric cancer

Non Gastric Cancer

Healthy controls or patients with histologically confirmed precancerous gastric lesions that have not yet progressed to malignancy.

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study recruits two main populations: patients with gastric cancer and non-gastric cancer participants. The latter group includes two subgroups: individuals with precancerous gastric lesions and healthy controls.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

Serum sample

MeSH Terms

Conditions

Stomach Neoplasms; Disease

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zhaoqing Tang

CONTACT

+86 64041990; tang.zhaoqing@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 31, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): June 30, 2029
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share