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Active, Not Recruiting

NCT Number: NCT06232538

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with gallbladder disease and planned to undergo surgery.
  • Male or female patients aged >= 18 years.
  • Participants signed informed consent form.

Exclusion criteria

  • Participants had other tumor expect gallbladder cancer

Treatment and study plan

The level of CNV

Diagnostic Test

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.

Primary outcomes

  1. UCAD can be used as a diagnostic technology for gallbladder cancer with the sensitivity more than 90%

    Time frame: 2025

    Ultrasensitive chromosomal aneuploidy detection (UCAD) uses low-coverage whole-genome sequencing technology to detect DNA chromosomal instability in samples. By detecting DNA extracted from patients' bile and blood, bioinformatics can be used to analyze the differences in CNV between benign and malignant gallbladder diseases, and a prediction model for gallbladder cancer.

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • Affiliated Hospital of North Sichuan Medical College
  • Changhai Hospital
  • Eastern Hepatobiliary Surgery Hospital
  • First Affiliated Hospital Xi'an Jiaotong University
  • First Affiliated Hospital of Zhejiang University
  • Jiangsu Provincial People's Hospital
  • Ruijin Hospital
  • Second Hospital of Jilin University
  • Shanghai Changzheng Hospital
  • Shanghai Zhongshan Hospital
  • Southwest Hospital, China
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • Third Affiliated Hospital, Sun Yat-Sen University
  • West China Hospital

Registry information

Official study title

A Prospective, Multi-centre, Single-blinded Study of UCAD for Diagnosing Benign or Malignant Gallbladder Diseases and Follow-up

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2024
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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