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

Status: Unknown
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

Chromosomal instability (CIN) refers to ongoing chromosome segregation errors throughout consecutive cell divisions. CIN is a hallmark of human cancer, and it is associated with poor prognosis, metastasis, and therapeutic resistance. Analyzing CIN of the DNA extracted from bile tract exfoliated cells in bile samples seems a promising method for diagnosing, monitoring, and predicting the prognosis of patients with malignant biliary obstruction, including biliary tract cancer (BTC), pancreatic head carcinoma. CIN 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 CIN thus helping diagnose malignant biliary obstruction and assessing follow-up.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients diagnosed with malignant biliary obstruction and planned to undergo ERCP(endoscopic retrograde cholangiopancreatography), PTCS(percutaneous transhepatic cholangioscopy) or surgery.

• Malignant biliary obstruction patients confirmed by operation or biopsy.

• Participants without any tumor disease and willing to attend the study.

• Male or female patients aged \>= 18 years.

• Participants signed informed consent form.

Locations
Other Locations
China
Xinhua Hospital
RECRUITING
Shanghai
Contact Information
Primary
Jiandong Wang, M.D., Ph.D.
wangjiandongdr@163.com
+86 13801932014
Backup
Tianyu Zhai, M.D., Ph.D.
937554343@qq.com
+8619916934772
Time Frame
Start Date: 2021-09-03
Completion Date: 2024-03
Participants
Target number of participants: 400
Treatments
malignant biliary obstruction
Pre-surgery patients with malignant biliary obstruction will be the experimental group to determine the sensitivity and specificity of UCAD analysis, the result will be compared with cytology.
Benign biliary obstruction
Patients being treated for other biliary diseases but without any tumor will provide a negative control to provide data for determining the sensitivity and specificity of UCAD analysis.
Sponsors
Collaborators: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Ruijin Hospital, First Affiliated Hospital Xi'an Jiaotong University, West China Hospital, Shanghai Changzheng Hospital, Eastern Hepatobiliary Surgery Hospital, Third Affiliated Hospital, Sun Yat-Sen University, Changhai Hospital, Second Hospital of Jilin University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Jiangsu Provincial People's Hospital, First Affiliated Hospital of Zhejiang University, Southwest Hospital, China, Shanghai Zhongshan Hospital, Affiliated Hospital of North Sichuan Medical College
Leads: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

This content was sourced from clinicaltrials.gov