Screening and Validation of Serum Protein Biomarkers for Early Diagnosis of Gastric Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Gastric Cancer (Diagnosis). Basic parameters: 18 years — 95 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Diagnostic Performance of the Serum Protein Biomarker-Based Model for Gastric Cancer [Time frame: 3 years]
Secondary outcome measures (3)
- 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 response to neoadjuvant therapy in gastric cancer [Time frame: 3 years]
- Prognostic performance of the serum protein model in gastric cancer patients [Time frame: 3 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07096752 · B2025-308R