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

NCT06232538 | Active Not Recruiting

• 1 other identifier: XH-24-001
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

diagnosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

gallbladder cancer

Diagnostic Test: The level of CNV

benign gallbladder diseases

Diagnostic Test: The level of CNV

Interventions

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.

benign gallbladder diseases; gallbladder cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with malignant biliary obstruction or participants in control group from February 2022 till the end of this study in 11 hospitals including Xinhua Hospital, Shanghai Zhongshan Hospital, Ruijin Hospital, Changhai Hospital, Shanghai Changzheng Hospital, Eastern Hepatobiliary Surgery Hospital, The First Affiliated Hospital of Xi'an Jiaotong University, Jiangsu Provincial Hospital, The Third Affiliated Hospital of Sun Yat-Sen University, Tianjin Medical University Second Hospital, First Affiliated Hospital of Zhejiang University

You may qualify if:

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

You may not qualify if:

• Participants had other tumor expect gallbladder cancer

Sponsors & Collaborators

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

Study Sites (1)

Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

Location

Related 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.

  PMID: 30178746 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

DNA from bile in the gallbladder will be analyzed

MeSH Terms

Conditions

Gallbladder Neoplasms; Disease

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 30, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)