Malignant tumors of the gallbladder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients who underwent surgical resection of the gallbladder at the main study center or any of the sub-centers between January 1, 2016, and February 28, 2023, with a pathological diagnosis of gallbladder cancer. 2.Aged 18–74 years, regardless of gender. 3.Karnofsky Performance Status (KPS) score > 50. 4.Patients must pass quality control by the research team, with at least one paraffin specimen containing > 50% cancerous tissue and at least one paraffin specimen of non-cancerous tissue from the same patient. 5.The pathology departments of collaborating centers must meet the following criteria during tissue fixation and diagnosis: Strictly adhere to the national pathological tissue fixation standards during tissue fixation: fresh specimens must be fixed with 10% neutral formalin within 30 minutes after excision, and the volume of fixative must be no less than 4 times that of the specimen. At least two pathologists in the center must stage gallbladder cancer specimens in accordance with the 8th edition of the TNM staging system jointly released by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC), and determine the pathological type based on the WHO Gallbladder Cancer Pathology Guidelines published in 2010.
Exclusion criteria
Exclusion criteria: 1.Gallbladder cancer patients with concurrent other primary malignant tumors. 2.Gallbladder cancer patients complicated with severe central nervous system diseases, respiratory diseases, autoimmune diseases, chronic renal insufficiency, or other such conditions; those on long-term immunosuppressant use; or those with severe uncontrolled infections. 3.Gallbladder cancer patients with active cardiovascular and cerebrovascular diseases, including a history of cerebrovascular accident, myocardial infarction, or unstable angina within 6 months; congestive heart failure of New York Heart Association (NYHA) Class II or higher; or severe arrhythmias requiring medication. 4.Gallbladder cancer patients who are pregnant or lactating women; women of childbearing age with a positive blood pregnancy test or those who have not undergone a pregnancy test. 5.Gallbladder cancer patients who have participated in other therapeutic clinical trials with unclear treatment measures or unavailable treatment information during their illness.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival; | — |
Primary
| Measure | Time frame |
|---|---|
| Overall survival time; | — |
Countries
China
Contacts
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine