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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-74
SponsorRenJi Hospital

About this trial

The aim of the study is to establishing a standardized biobank and a clinical information database for patients with benign and malignant tumors of the biliary system. With follow-up plans and advanced multiomics technology, a multiomics database for patients with benign and malignant tumors of the biliary tract will be further established. Based on the above work, real-world clinical research on the diagnosis and treatment of biliary tract tumors is about to be carried out, and a high-standard cohort research foundation is laid for precision therapy based on multiomics characteristics and molecular typing of biliary tract tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sign informed consent, have good compliance, and be willing to accept follow-up and provide blood samples.

Age 18-74 years old, gender is not limited.

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.

The primary tumor is located in the extrahepatic bile duct, intrahepatic bile duct, gallbladder floor, gallbladder body, gallbladder neck or gallbladder duct.

Disqualifiers

Patients with biliary malignant tumors, biliary malignant tumor foci are not primary lesions.

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.

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.

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.

Trial population

Patients with benign biliary tumors and biliary malignant tumors diagnosed by pathology, and combined with clinical manifestations and imaging results, the first diagnosis and discharge were diagnosed as patients with advanced biliary malignant tumors.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • no interventions

    Other intervention

    no interventions

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Patients with benign or malignant tumors of the biliary system1 intervention

Trial outcomes

Primary outcomes

1

overall survival

OS in patients with biliary malignancies was long-term follow-up data, defined as the primary endpoint, OS is calculated from the date of surgery for patients treated surgically, and OS is calculated from the date of diagnosis for patients treated non-surgically. The expected survival of patients with benign biliary tumors is longer, and this study does not select the study endpoint based on the follow-up of patients with benign biliary tumors, but mainly collects perioperative diagnosis and treatment data and collects biological samples.

Time frame
The last follow-up ended with the first of all patients followed up to death, loss to follow-up or withdrawal of informed consent, or follow-up for 2 years.

Secondary outcomes

1

progression-free survival

PFS was defined as a secondary endpoint. PFS is calculated from the date of surgery for patients treated surgically, and PFS is calculated from the date of diagnosis for patients treated non-surgically. The expected survival of patients with benign biliary tumors is longer, and this study does not select the study endpoint based on the follow-up of patients with benign biliary tumors, but mainly collects perioperative diagnosis and treatment data and collects biological samples.

Time frame
The last follow-up ended with the first of all patients followed up to death, loss to follow-up or withdrawal of informed consent, or follow-up for 2 years.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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