Study to Assess the Feasibility in Bile cfDNA of Resectable Biliary Tract Carcinomas

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Single-Center Exploratory Study to Assess the Feasibility in Bile cfDNA of Resectable Biliary Tract Carcinomas by Using Burning Rock Gene Testing Platform

Conditions
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This Study Aims to Reveal the Effectiveness, Accuracy, and Feasibility in Bile

Intervention / Treatment
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* Diagnostic Test: Next generation sequencing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: a.Patients who be deemed unsuitable for enrollment by the researchers.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| bile group<br>bile samples from 20 resectable BTC patients with 520 Panel sequencing (bile10000X) | Diagnostic Test: Next generation sequencing<br>* Extract DNA from bile，tissue and tissue sample, minimum DNA amount should be over 50ng.<br>|
| Tissue group<br>tissue samples from 20 resectable BTC patients with 520 Panel sequencing (tissue1000X) | Diagnostic Test: Next generation sequencing<br>* Extract DNA from bile，tissue and tissue sample, minimum DNA amount should be over 50ng.<br>|
| Plasma group<br>plasma samples from 20 resectable BTC patients with 520 Panel sequencing (plasma 10000X) | Diagnostic Test: Next generation sequencing<br>* Extract DNA from bile，tissue and tissue sample, minimum DNA amount should be over 50ng.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare different sample types with concordence rate, sensitivity, and specificity. | 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. | 1 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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resectable BTC，tissue, blood , and bile samples，genomic alterations