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

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

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.

Study Overview

• Status: Recruiting
• Conditions: This Study Aims to Reveal the Effectiveness, Accuracy, and Feasibility in Bile
• Intervention / Treatment: Diagnostic test: Next generation sequencing

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Changzhen Shang, MD; Phone Number: 13711279678; Email: shangchangzhen@139.com
• Study Contact Backup: Name: Songyao Liu, MD; Phone Number: 13754858677; Email: liusy229@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510289
      • Recruiting
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
      • Contact: Songyao Liu, MD; Phone Number: 13754858677; Email: liusy229@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Planning to enroll 20 resectable BTC patients, age over 18 years old following the eligibility criteria.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
bile group; bile samples from 20 resectable BTC patients with 520 Panel sequencing (bile10000X)	Diagnostic test: Next generation sequencing; 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)	Diagnostic test: Next generation sequencing; 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)	Diagnostic test: Next generation sequencing; Extract DNA from bile，tissue and tissue sample, minimum DNA amount should be over 50ng.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Principal Investigator: Changzhen Shang, MD, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): February 2, 2024

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: resectable BTC，tissue, blood , and bile samples，genomic alterations
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma
• Other Study ID Numbers: SYSKY-2023-043-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No