UCAD for Diagnosing Benign or Malignant Gallbladder Diseases and Follow-up

NCT06232538 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2024-02-01

No results posted yet for this study

Summary

Copy number variation(CNV) refers to ongoing chromosome segregation errors throughout consecutive cell divisions. CNV is a hallmark of human cancer, and it is associated with poor prognosis, metastasis, and therapeutic resistance. Analyzing CNV of the DNA extracted from bile samples in gallbladder seems a promising method for diagnosing, monitoring, and predicting the prognosis of patients with gallbladder cancer. CNV 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 Ultrasensitive Chromosomal Aneuploidy Detection (UCAD), which is based on low-coverage whole-genome sequencing, can be used to analyze CNV thus helping diagnose gallbladder cancer and assessing follow-up.

Conditions

  • Gallbladder Cancer

Interventions

DIAGNOSTIC_TEST

The level of CNV

The extracted DNA from bile will be analyzed by UCAD to determine the level of CNV. And the patient will be followed more than 1 year.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    collaborator OTHER
  • Ruijin Hospital

    collaborator OTHER
  • Changhai Hospital

    collaborator OTHER
  • Shanghai Changzheng Hospital

    collaborator OTHER
  • Eastern Hepatobiliary Surgery Hospital

    collaborator OTHER
  • First Affiliated Hospital Xi'an Jiaotong University

    collaborator OTHER
  • Jiangsu Provincial People's Hospital

    collaborator OTHER
  • Third Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER
  • First Affiliated Hospital of Zhejiang University

    collaborator OTHER
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    collaborator OTHER
  • Second Hospital of Jilin University

    collaborator OTHER
  • West China Hospital

    collaborator OTHER
  • Southwest Hospital, China

    collaborator OTHER
  • Affiliated Hospital of North Sichuan Medical College

    collaborator OTHER
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    collaborator OTHER
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2026-01-31
Completion
2026-08-31

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 NCT06232538 on ClinicalTrials.gov