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Trial Title:
Study to Assess the Feasibility in Bile cfDNA of Resectable Biliary Tract Carcinomas
NCT ID:
NCT05783973
Condition:
This Study Aims to Reveal the Effectiveness, Accuracy, and Feasibility in Bile
Conditions: Official terms:
Carcinoma
Conditions: Keywords:
resectable BTC，tissue, blood , and bile samples，genomic alterations
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Next generation sequencing
Description:
Extract DNA from bile，tissue and tissue sample, minimum DNA amount should be over 50ng.
Arm group label:
Plasma group
Arm group label:
Tissue group
Arm group label:
bile group
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.
Criteria for eligibility:
Study pop:
Planning to enroll 20 resectable BTC patients, age over 18 years old following the
eligibility criteria.
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Address:
City:
Guangzhou
Zip:
510289
Country:
China
Status:
Recruiting
Contact:
Last name:
Songyao Liu, MD
Phone:
13754858677
Email:
liusy229@mail.sysu.edu.cn
Start date:
February 2, 2023
Completion date:
February 2, 2024
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05783973
