AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Biliary Tract Cancer (ASCEND-BTC)
Recruiting
- Conditions
- Biliary Tract Cancer
- Interventions
- Other: Blood drawing
- Registration Number
- NCT05667350
- Lead Sponsor
- Eastern Hepatobiliary Surgery Hospital
- Brief Summary
ASCEND-BTC is a prospective, multi-center, observational study aimed at detecting early biliary tract cancer by combined assays of serum protein and cell-free DNA (cfDNA) methylation. The study will enroll approximately 492 participants diagnosed with biliary tract cancer and benign diseases.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 492
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Benign disease arm Blood drawing Baseline blood samples will be collected from participants newly diagnosed with benign biliary tract diseases. Cancer arm Blood drawing Baseline blood samples will be collected from participants newly diagnosed with biliary tract cancer.
- Primary Outcome Measures
Name Time Method The sensitivity and specificity of the combined model in detection of biliary tract cancers. 24 months
- Secondary Outcome Measures
Name Time Method The sensitivity and specificity of the combined model in detection of different stages of biliary tract cancers. 24 months The sensitivity and specificity of the combined model in detection of different subtypes of biliary tract cancers. 24 months
Trial Locations
- Locations (2)
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Eastern Hepatobiliary Surgery Hospital
🇨🇳Shanghai, Shanghai, China