A Prospective Study of UCAD for Diagnosing Benign or Malignant Biliary Obstruction and Follow-up

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.

Conditions

• Biliary Tract Neoplasms
• Pancreatic Carcinoma
• Gallbladder Cancer
• Pancreatic Head Carcinoma

Interventions

DIAGNOSTIC_TEST

The level of CIN

The extracted DNA from bile will be analyzed by UCAD to determine the level of CIN. And the patient will be followed for up to 2 years.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital

  collaborator OTHER

• Ruijin Hospital

  collaborator OTHER

• Changhai Hospital

  collaborator OTHER

• Shanghai Changzheng Hospital

  collaborator OTHER

• Eastern Hepatobiliary Surgery Hospital

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• Jiangsu Provincial People's Hospital

  collaborator OTHER

• Third Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  collaborator OTHER

• Second Hospital of Jilin University

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Southwest Hospital, China

  collaborator OTHER

• Affiliated Hospital of North Sichuan Medical College

  collaborator OTHER

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  lead OTHER

Principal Investigators

• Jiandong Jiandong, M.D., Ph.D. · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-03

Primary Completion

2023-09-30

Completion

2024-03-31

Countries

• China

Study Locations