iDentification and vAlidation Model of Liquid biopsY Based cfDNA Methylation and pRotEin biomArKers for Pancreatic Cancer (DAYBREAK Study)
- Conditions
- Cancer
- Registration Number
- NCT05495685
- Lead Sponsor
- Changhai Hospital
- Brief Summary
DAYBREAK is a prospective, multi-omics, observational study aimed at early detecting pancreatic cancer by combined assays for biomarkers of cfDNA methylation, serum protein markers, blood miRNA markers and others, in which of 450 participants will be enrolled. The development and validation of the model will be conducted in participants with early stage cancers and benign disease through a two-stage approach. The sensitivity and specificity of the model in pancreatic cancer early detection will be evaluated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 450
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The sensitivity and specificity of multi-cancer early detection by the combined model in cancer arm and benign disease arm 12 months
- Secondary Outcome Measures
Name Time Method The difference of sensitivity and specificity in pancreatic cancer participants at different clinical stages. 12 months Sensitivity and specificity for detecting pancreatic cancer of a cfDNA methylation-based model, in combination with other biomarkers. 12 months Sensitivity and specificity for detecting pancreatic cancer of a the protein panel-based model, in combination with other biomarkers. 12 months Sensitivity and specificity of the blood miRNA-based model in detecting pancreatic cancer. 12 months
Trial Locations
- Locations (1)
Shanghai Changhai Hospital
🇨🇳Shanghai, Shanghai, China