Study to Assess the Feasibility in Bile cfDNA of Resectable Biliary Tract Carcinomas
- Conditions
- This Study Aims to Reveal the Effectiveness, Accuracy, and Feasibility in Bile
- Interventions
- Diagnostic Test: Next generation sequencing
- Registration Number
- NCT05783973
- Brief Summary
This study intends to use Onconscreen plus 520 Panel (Burning Rock, China) to conduct NGS testing in matched tissue, blood , and bile samples of patients with Resectable Biliary Tract Carcinomas（BTC）. In order to explore thefeasibility in bile cfDNA of BTC，we will collect relevant clinical information and follow-up treatment information. This study aims to reveal the effectiveness, accuracy, and feasibility in bile, as compared to tissues and blood samples.
- Detailed Description
In this study, we will investigate the potential of bile for genomic alterations using matched tissue, plasma and bile from 20 Resectable BTC Patients。The patient samples will be submitted for next-generation sequencing (NGS)，The results will include but will not be limited to genomic profling, tumor mutation burden (TMB), microsatellite instability (MSI) status, homologous recombination repair deficiency (HRD)。Patients will be followed-up for treatment responses until radiological confirmation of disease recurrence ,The molecular assay results will then be analyzed with clinical data including objective responses disease-free survival outcomes, among others, to reveal the effectiveness, accuracy, and feasibility in bile, as compared to tissues and blood samples.
Baseline tissues, plasma and sputum samples from 20 Resectable BTC Patients with 520 Panel sequencing (tissue 1000X, ,plasma cfDNA 10000X，bile 10000X), in different methods will be compared.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Patients who are diagnosed with diagnosed with BTC (including IHCC、EHCC、GBC)by histology or cytology
- Patients who signed informed consent form;
- Patients who agree and have the ability to follow the planned research visits, provide surgical tissue, blood, and bile samples, provide clinical information, and cooperate with other research steps.
a.Patients who be deemed unsuitable for enrollment by the researchers.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description bile group Next generation sequencing bile samples from 20 resectable BTC patients with 520 Panel sequencing (bile10000X) Tissue group Next generation sequencing tissue samples from 20 resectable BTC patients with 520 Panel sequencing (tissue1000X) Plasma group Next generation sequencing plasma samples from 20 resectable BTC patients with 520 Panel sequencing (plasma 10000X)
- Primary Outcome Measures
Name Time Method Compare different sample types with concordence rate, sensitivity, and specificity. 1 years Concordance rate was defined as the fraction of the total number of true positive and true negative patients relative to the cohort or indicated subgroup; Sensitivity rate means true positive rate, true positive patients were defined as those who carried at least one genomic alteration that were detected in both matched samples.
Specificity rate means ture negative rate, patients were as defined true negative if no alteration was detected from either matched sample.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China