Clinical trial NCT05783973: Study to Assess the Feasibility in Bile cfDNA of Resectable Biliary Tract Carcinomas
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: This Study Aims to Reveal the Effectiveness, Accuracy, and Feasibility in Bile
Keywords: resectable BTC，tissue, blood , and bile samples，genomic alterations
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Planning to enroll 20 resectable BTC patients, age over 18 years old following the eligibility criteria.

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.

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.

Primary outcomes:
measure: Compare different sample types with concordence rate, sensitivity, and specificity.
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Changzhen Shang, MD
role: PRINCIPAL_INVESTIGATOR
References: