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

Gallbladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06232538
• Other study ID #: XH-24-001
• Status: Active, not recruiting
• Start date: January 1, 2024
• Est. completion date: August 2026

Study information

• Verified date: January 2024
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1
• Est. completion date: August 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gallbladder Cancer
• Gallbladder Diseases
• Gallbladder Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Xinhua Hospital	Shanghai	Shanghai

Sponsors (16)

Lead Sponsor

Collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Af?liated Hospital of North Sichuan Medical College, Changhai Hospital, Eastern Hepatobiliary Surgery Hospital, First Affiliated Hospital of Zhejiang University, First Affiliated Hospital Xi'an Jiaotong 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

Country where clinical trial is conducted

China, 

References & Publications (1)

Hieronymus H, Murali R, Tin A, Yadav K, Abida W, Moller H, Berney D, Scher H, Carver B, Scardino P, Schultz N, Taylor B, Vickers A, Cuzick J, Sawyers CL. Tumor copy number alteration burden is a pan-cancer prognostic factor associated with recurrence and death. Elife. 2018 Sep 4;7:e37294. doi: 10.7554/eLife.37294. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UCAD can be used as a diagnostic technology for gallbladder cancer with the sensitivity more than 90%	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.	2025