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

Sun Yat-sen University

Status: Enrolling

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

Treatments: Diagnostic Test: Next generation sequencing

Study type: Observational

Funder types: Other

Identifiers

NCT05783973

SYSKY-2023-043-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

20 participants in 3 patient groups

bile group

Description:

bile samples from 20 resectable BTC patients with 520 Panel sequencing (bile10000X)

Treatment:

Diagnostic Test: Next generation sequencing

Tissue group

Description:

tissue samples from 20 resectable BTC patients with 520 Panel sequencing (tissue1000X)

Treatment:

Diagnostic Test: Next generation sequencing

Plasma group

Description:

plasma samples from 20 resectable BTC patients with 520 Panel sequencing (plasma 10000X)

Treatment:

Diagnostic Test: Next generation sequencing