The Construction of Clinical Database and Multiomics Biobank Based on a Multicentral Prospective Cohort of Benign and Malignant Biliary Tract Diseases

Launched by RENJI HOSPITAL · Jun 1, 2023

Keywords

ClinConnect Summary

This clinical trial aims to create a detailed database and biobank for patients with both non-cancerous and cancerous conditions affecting the biliary system, which includes the gallbladder and bile ducts. The goal is to gather information and samples from patients to better understand these diseases and improve diagnosis and treatment options in the future. The researchers will use advanced techniques to analyze the genetic and molecular features of these tumors, which will help develop more personalized treatment approaches.

To be eligible for this study, participants need to be between 18 and 74 years old and have been diagnosed with a tumor in the biliary system, either benign or malignant. They must be willing to provide blood samples and follow-up information. However, certain individuals, such as those with serious other health conditions or who are pregnant, may not be able to participate. If you join the study, you can expect to contribute to important research that could benefit future patients with similar conditions, while also receiving regular follow-up and support from the research team.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Sign informed consent, have good compliance, and be willing to accept follow-up and provide blood samples.
• • 2. Age 18-74 years old, gender is not limited.
• • 3. Clinical diagnosis of benign and malignant tumors of the biliary system, including unoperated patients preliminarily diagnosed as benign and malignant tumors of the biliary tract according to the results of imaging examinations and laboratory tests, or pathological examination of patients treated with surgery confirmed as benign and malignant tumors of the gallbladder.
• • 4. The primary tumor is located in the extrahepatic bile duct, intrahepatic bile duct, gallbladder floor, gallbladder body, gallbladder neck or gallbladder duct.
• • 5. Karnofsky performance score greater than 50.
• Exclusion Criteria:
• • 1. Patients with biliary malignant tumors, biliary malignant tumor foci are not primary lesions.
• • 2. Patients with biliary malignant tumors, combined with serious central nervous system diseases, respiratory diseases, autoimmune diseases, chronic renal insufficiency and other diseases, long-term use of immunosuppressants, combined with serious uncontrolled infections.
• • 3. Patients with biliary malignant tumors, who also have active cardiovascular and cerebrovascular diseases, have cerebrovascular accidents, myocardial infarction, unstable angina pectoris, or grade II. or above congestive heart failure according to the standards of the New York Heart Association, and require serious arrhythmias requiring drug treatment.
• • 4. Patients with biliary malignant tumors, women of childbearing age who have a positive blood pregnancy test or have not had a pregnancy test, pregnant or breastfeeding women.
• • 5. The patient is participating in other therapeutic clinical trials where treatment measures cannot be clarified or treatment information cannot be collected.