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Application of Chromosomal Instability in Early Diagnosis of Biliary Tract Carcinoma

NCT05845554 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2023-12-18

No results posted yet for this study

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.

Conditions

  • Biliary Tract Carcinoma

Interventions

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.

Sponsors & Collaborators

  • Taizhou First People's Hospital

    collaborator OTHER

  • First Affiliated Hospital of Wenzhou Medical University

    collaborator OTHER

  • Sir Run Run Shaw Hospital

    collaborator OTHER

  • Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

    lead OTHER

Principal Investigators

  • fabiao zhang · Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

  • yunfeng shan · First Affiliated Hospital of Wenzhou Medical University

  • ning mu · Taizhou First People's Hospital

  • xiao liang · Sir Run Run Shaw Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-30
Primary Completion
2023-12-30
Completion
2024-04-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05845554 on ClinicalTrials.gov