Official Title
A Single-Center Exploratory Study to Assess the Feasibility in Bile cfDNA of Resectable Biliary Tract Carcinomas by Using Burning Rock Gene Testing Platform
Brief Title
Study to Assess the Feasibility in Bile cfDNA of Resectable Biliary Tract Carcinomas
Protocol ID
NCT05783973
Lead Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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.
Study Period
-
Enrollment Count
20 participants
Eligibility Criteria
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.
Filters
This Study Aims to Reveal the Effectiveness, Accuracy, and Feasibility in Bile
UNKNOWN
ADULT
OLDER_ADULT