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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05783973
Recruitment Status : Recruiting
First Posted : March 24, 2023
Last Update Posted : May 30, 2023
Sponsor:
Information provided by (Responsible Party):
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Description
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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.

Condition or disease Intervention/treatment
This Study Aims to Reveal the Effectiveness, Accuracy, and Feasibility in Bile 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 Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : February 2, 2023
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : February 2, 2024
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Compare different sample types with concordence rate, sensitivity, and specificity. [ Time Frame: 1 years ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05783973


Contacts
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Contact: Changzhen Shang, MD 13711279678 shangchangzhen@139.com
Contact: Songyao Liu, MD 13754858677 liusy229@mail.sysu.edu.cn

Locations
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China, Guangdong
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510289
Contact: Songyao Liu, MD    13754858677    liusy229@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
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Principal Investigator: Changzhen Shang, MD Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
More Information
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Responsible Party: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT05783973    
Other Study ID Numbers: SYSKY-2023-043-02
First Posted: March 24, 2023    Key Record Dates
Last Update Posted: May 30, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University:
resectable BTC，tissue, blood , and bile samples，genomic alterations
Additional relevant MeSH terms:
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Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms