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

NCT05783973 | Unknown

• 1 other identifier: SYSKY-2023-043-02
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

resectable BTC，tissue, blood , and bile samples，genomic alterations

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

bile group

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

Diagnostic Test: Next generation sequencing

Tissue group

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

Diagnostic Test: Next generation sequencing

Plasma group

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

Diagnostic Test: Next generation sequencing

Interventions

Next generation sequencing DIAGNOSTIC_TEST

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

Plasma group; Tissue group; bile group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patients who are diagnosed with diagnosed with BTC (including IHCC、EHCC、GBC)by histology or cytology
• Patients who signed informed consent form;
• 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.

You may not qualify if:

• a.Patients who be deemed unsuitable for enrollment by the researchers.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510289, China

RECRUITING

Study Officials

• Changzhen Shang, MD

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changzhen Shang, MD

CONTACT

13711279678; shangchangzhen@139.com

Songyao Liu, MD

CONTACT

13754858677; liusy229@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 24, 2023
• Study Start: February 2, 2023
• Primary Completion: December 31, 2023
• Study Completion: February 2, 2024
• Last Updated: May 30, 2023

Record last verified: 2023-02

Locations

CN (1)