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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-02

Study Completion Date

2024-02-02

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.

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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bile group

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

Next generation sequencing

Intervention Type DIAGNOSTIC_TEST

Extract DNA from bile，tissue and tissue sample, minimum DNA amount should be over 50ng.

Tissue group

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

Next generation sequencing

Intervention Type DIAGNOSTIC_TEST

Extract DNA from bile，tissue and tissue sample, minimum DNA amount should be over 50ng.

Plasma group

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

Next generation sequencing

Intervention Type DIAGNOSTIC_TEST

Extract DNA from bile，tissue and tissue sample, minimum DNA amount should be over 50ng.

Interventions

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Next generation sequencing

Extract DNA from bile，tissue and tissue sample, minimum DNA amount should be over 50ng.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.