AssesSment of Early-deteCtion basEd oN liquiD Biopsy in GASTRIC Cancer, ASCEND-Gastric
- Conditions
- Cancer
- Interventions
- Diagnostic Test: Blood draw and blood-based biomarkers analyses
- Registration Number
- NCT05224596
- Lead Sponsor
- Shanghai Zhongshan Hospital
- Brief Summary
ASCEND-Gastric is a prospective, multi-omics, observational study aimed at detecting gastric cancer by combined assays for serum protein markers, deep sequencing of cell-free DNA (cfDNA), circulating tumor DNA (ctDNA) mutation and circulating RNA. The study will enroll 498 participants, including 128 patients with benign gastric diseases and 370 patients with gastric cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 498
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Benign disease arm Blood draw and blood-based biomarkers analyses Baseline blood samples will be collected from new diagnosis benign gastric disease participants. Cancer arm Blood draw and blood-based biomarkers analyses Baseline blood samples will be collected from new diagnosis cancer participants.
- Primary Outcome Measures
Name Time Method Sensitivity and specificity of the cfDNA methylation-based model in detecting gastric cancer. 30 months
- Secondary Outcome Measures
Name Time Method Sensitivity and specificity for detecting gastric cancer of a cfDNA methylation-based model, in combination with other biomarkers. 30 months The differences of sensitivity and specificity in gastric cancer participants at different clinical stages. 30 months Sensitivity and specificity of a ctDNA mutation-based model and a serum protein-based model in detecting gastric cancer, respectively. 30 months
Trial Locations
- Locations (1)
ZhongShan hospital FuDan university
🇨🇳Shanghai, Shanghai, China