The Construction of Clinical Database and Multiomics Biobank Based on a Multicentral Prospective … (NCT05896956) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Construction of Clinical Database and Multiomics Biobank Based on a Multicentral Prospective Cohort of Benign and Malignant Biliary Tract Diseases
500 participantsStarted 2023-07-01
Plain-language summary
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.
Who can participate
Age range18 Years – 74 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Karnofsky performance score greater than 50.
Exclusion criteria
✕. 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.
What they're measuring
1
overall survival
Timeframe: 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.
✕. 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.
✕. The patient is participating in other therapeutic clinical trials where treatment measures cannot be clarified or treatment information cannot be collected.