This Study Aims to Reveal the Effectiveness, Accuracy, and Feasibility in Bile
Conditions
Keywords
resectable BTC，tissue, blood , and bile samples，genomic alterations
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.
Interventions
DIAGNOSTIC_TESTNext generation sequencing
Extract DNA from bile，tissue and tissue sample, minimum DNA amount should be over 50ng.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who are diagnosed with diagnosed with BTC (including IHCC、EHCC、GBC)by histology or cytology 2. Patients who signed informed consent form; 3. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactChangzhen Shang, MD
Backup ContactSongyao Liu, MD
Outcome results
None listed