Serum Protein Biomarkers for Early Gastric Cancer Detection
This observational study aims to evaluate the diagnostic performance of a serum protein biomarker-based model to detect early stage gastric cancer, helping improve gastric cancer screening and outcomes.
Data Collection
Collected from today forward - ProspectiveDigestive System Diseases+8
+ Digestive System Neoplasms
+ Disease
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: August 1, 2025
Actual date on which the first participant was enrolled.This study aims to find new ways to detect gastric cancer early by identifying specific proteins in the blood that are linked to the disease. Researchers are using advanced technology to analyze blood samples from many people to discover these proteins, called biomarkers. The goal is to create new tests that can detect gastric cancer sooner, which is crucial because early detection can significantly improve treatment outcomes and survival rates for patients. Participants involved in this study provide blood samples, which are then analyzed using special equipment to find these protein biomarkers. The study observes how effectively these proteins can tell the difference between those with gastric cancer and those without. By measuring how accurate and reliable these biomarkers are, the study hopes to develop better diagnostic methods that are less invasive, making it easier and more comfortable for people to get tested. The study measures the success of these new methods by looking at their sensitivity, which shows how well they detect cancer, and specificity, which shows how accurately they can rule out those without the disease.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 95 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives