NCT06232538

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-01-01
• Completion: 2026-08-01
• First posted: 2024-01-30
• Last updated: 2024-02-01

Locations

1 site across 1 country: China