Construction of Multicenter Retrospective Registry Cohort Database for Gallbladder Cancer
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 clinical information database for patients with malignant tumors of gallbaldder. Based on the database, 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 gallbladder cancer, including unoperated patients preliminarily diagnosed as gallbladder cancer according to the results of imaging examinations and laboratory tests, or pathological examination of patients treated with surgery confirmed as malignant tumors of the gallbladder.
The primary tumor is located in gallbladder floor, gallbladder body, gallbladder neck or gallbladder duct.
Disqualifiers
Patients with gallbladder cancer, gallbladder cancer foci are not primary lesions.
Patients with gallbladder cancer, 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 gallbladder cancer, 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 gallbladder cancer, 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 gallbladder cancer diagnosed by pathology, and combined with clinical manifestations and imaging results, the first diagnosis and discharge were diagnosed as patients with gallbladder cancer.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
no interventions
Other interventionretrospective registry cohort with no other specific interventions
Treatment groups
5,000 Participants
are divided into 1 treatment groupGroup A: Gallbladder cancer1 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
From date of enrollment until the date of death from any cause, whichever came first, assessed up to 5-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
From date of enrollment until the date of first documented progression from any cause, whichever came first, assessed up to 5-years.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: