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Application of Chromosomal Instability in Early Diagnosis of Biliary Tract Carcinoma

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ClinicalTrials.gov Identifier: NCT05845554
Recruitment Status : Recruiting
First Posted : May 6, 2023
Last Update Posted : December 18, 2023
Sponsor:
Collaborators:
Taizhou First People's Hospital
First Affiliated Hospital of Wenzhou Medical University
Sir Run Run Shaw Hospital
Information provided by (Responsible Party):
Fabiao zhang, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Study Description
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Brief Summary:
Chromosomal instability (CIN) refers to ongoing chromosome segregation errors throughout consecutive cell divisions. CIN is a hallmark of human cancer, and it is associated with poor prognosis, metastasis, and therapeutic resistance. Analyzing CIN of the DNA extracted from cast-off cells in bile samples seems a promising method for diagnosing, monitoring, and predicting the prognosis of biliary tract carcinoma patients. CIN can be assessed using experimental techniques such as bulk DNA sequencing, fluorescence in situ hybridization (FISH), or conventional karyotyping. However, these techniques are either time-consuming or non-specific. The investigators here intend to study whether a new method named Bile Ultrasensitive Chromosomal Aneuploidy Detection (BileCAD), which is based on low-coverage whole-genome sequencing, can be used to analyze CIN and microbial infection analysis thus help diagnosing and treating biliary tract carcinoma patients.

Condition or disease Intervention/treatment
Biliary Tract Carcinoma Diagnostic Test: The extracted DNA from bile samples will be analyzed by BileCAD to determine the level of CIN.

Detailed Description:
Biliary tract carcinoma account for about 3% of all digestive system tumors, with potential high metastasis and invasion ability. Their early clinical symptoms lack specificity, and they are often found in late stage with poor prognosis. CIN results from errors in chromosome segregation during mitosis, leading to structural and numerical chromosomal abnormalities. It will generate genomic heterogeneity that acts as a substrate for natural selection. Furthermore, it is proved that tumors with aneuploidies and polyploidy resulting from whole-genome doubling are related with metastasis, treatment resistance, and decreased overall survival. It is estimated that 60%-80% of human tumors exhibit chromosomal abnormalities suggestive of CIN. CIN positively correlates with tumor stage and is enriched in relapsed as well as metastatic tumor specimens. Due to the ubiquity of CIN in cancer cells, it is a potentially way to detect CIN in the cast-off cells from the bile samples for diagnosing and monitoring biliary tract carcinoma patients. BileCAD is a new method to detecting CIN in the DNA sample from patients, including extracting DNA from bile, analyzing DNA by low-coverage whole-genome sequencing, processing the data by bio-information techniques, and finally optimizing the management of biliary tract carcinoma patients.The investigators intended to conduct a prospective study by analyzing bile samples from gallbladder cancers and cholangiocarcinoma patients and control groups that without any tumor in the Bile duct and gallbladder or other organs to compare the specificity and sensitivity of BileCAD test for diagnosing biliary tract carcinoma to other modalities, such as pathological diagnosis. At the same time, the consistency of BileCAD microbial analysis results and clinical microbial culture results was compared, so as to provide more reference for clinical diagnosis.
Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Application of Chromosomal Instability and Metagenomic Detection in Early Diagnosis of Biliary Tract Carcinoma in Bile
Actual Study Start Date : March 30, 2023
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : April 1, 2024
Groups and Cohorts
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Group/Cohort Intervention/treatment
Biliary tract carcinoma patients
Biliary tract carcinoma patients will be the experimental group to determine the sensitivity of BileCAD analysis.
 Diagnostic Test: The extracted DNA from bile samples will be analyzed by BileCAD to determine the level of CIN.
The extracted gDNA from bile sample will be analyzed by BileCAD to determine the level of CINs.
Non-cancer participants Patients
Non-cancer participants Patients being treated for other diseases but without any tumor will provide a negative control to provide data for determining the specificity of BileCAD analysis.
 Diagnostic Test: The extracted DNA from bile samples will be analyzed by BileCAD to determine the level of CIN.
The extracted gDNA from bile sample will be analyzed by BileCAD to determine the level of CINs.


Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity of bile sample analysis by BileCADanalysis [ Time Frame: 12 months ]
    Number of patients "declared positive" with the BileCAD test among the patients suffered from biliary tract carcinoma.

  2. Specificity of bile sample analysis by BileCADanalysis [ Time Frame: 12 months ]
    Number of patients "declared negative" with the BileCAD test among the patients without cancer.


Secondary Outcome Measures :
  1. BileCAD microbial analysis results [ Time Frame: 12 months ]
    Consistency of BileCAD microbial analysis results with clinical microbial culture results

  2. BileCAD analyzed the sensitivity of different types and locations of malignant tumors [ Time Frame: 12 months ]
    The tumors were classified into different types and sites and the sensitivity of BileCAD to different types and sites of malignant tumors was calculated.


Biospecimen Retention:   Samples With DNA
DNA from cast-off cells in bile 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:   Non-Probability Sample
Study Population
Patients diagnosed with biliary tract carcinoma or participants in control group in Taizhou Hospital of Zhejiang Province, Taizhou First People's Hospital, The First Affiliated Hospital of Wenzhou Medical University and Sir Run Run Shaw Hospital from Apr 2023 until the end of this study.
Criteria

Inclusion Criteria:

  • No systemic therapy or biliary tract surgery before the trial.
  • Gallstones, bile duct space, obstructive jaundice and other suspected patients with biliary tract carcinoma.
  • Male or female patients aged >= 18 years.
  • Participants signed informed consent form.

Exclusion Criteria:

  • Age under 18 years.
  • Individuals unwilling to sign the consent form or unwilling to provide the medical record.
  • Individuals unwilling to participate in this trial.
  • Individuals has any active autoimmune disease or history of autoimmune disease.
  • Individuals have cardiac clinical symptoms or diseases that are not well controlled.
  • Individuals have uncontrolled severe cerebrovascular, pulmonary and other diseases.
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): NCT05845554


Contacts
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Contact: fabiao zhang 13706760105 zhangfabiao@enzemed.com

Locations
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China, Zhejiang
Sir Run Run Shaw Hospital, School of Medicine，Zhejiang University Recruiting
Hangzhou, Zhejiang, China
Contact: xiao liang    13588708506    srrshlx@zju.edu.cn   
Taizhou First People's Hospital Recruiting
Taizhou, Zhejiang, China
Contact: ning mu    15105861595    mnwsq@163.com   
Taizhou Hospital of Zhejiang Province Recruiting
Taizhou, Zhejiang, China
Contact: Fabiao zhang    13706760105    zhangfabiao@enzemed.com   
First Affiliated Hospital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China
Contact: yunfeng Shan    13857763998    shanyunfeng@wmu.edu.cn   
Sponsors and Collaborators
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Taizhou First People's Hospital
First Affiliated Hospital of Wenzhou Medical University
Sir Run Run Shaw Hospital
Investigators
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Principal Investigator: fabiao zhang Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Principal Investigator: yunfeng shan First Affiliated Hospital of Wenzhou Medical University
Principal Investigator: ning mu Taizhou First People's Hospital
Principal Investigator: xiao liang Sir Run Run Shaw Hospital
More Information
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Publications:

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Responsible Party: Fabiao zhang, department director, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT05845554    
Other Study ID Numbers: BileCAD-330
First Posted: May 6, 2023    Key Record Dates
Last Update Posted: December 18, 2023
Last Verified: December 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 Fabiao zhang, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University:
Biliary Tract Carcinoma
chromosomal instability
Additional relevant MeSH terms:
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Carcinoma
Chromosomal Instability
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Chromosome Aberrations
Pathologic Processes
Genomic Instability