NCT06276153

Construction of Multicenter Retrospective Registry Cohort Database for Gallbladder Cancer

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

From the date of commencement of the study, patients who presented to the participating medical institutions in the study and were clinically diagnosed as gallbladder cancer, and who met the inclusion criteria and did not meet any of the exclusion criteria, were enrolled in the study cohort after signing an informed consent form. The research objectives of this study mainly include establishing a structured dataset standard for gallbladder cancer based on the diagnosis and treatment norms and clinical pathways and carrying out clinical registration research on gallbladder cancer and build a specific disease cohort The outcome indicators of this study included overall survival time OS, recurrence-free survival time PFS, R0 resection rate of patients treated with biliary malignancy, and objective response rate ORR. The main measurement indicators of this study include the patient's demographic information, past history, life history, admission, preoperative examination information, surgery, postoperative situation, discharge, follow-up, outcome indicators, routine examination results of biological samples and multi-omics sequencing results, the above data are derived from the original records of prospective case questionnaires, the original records of patients' electronic medical records and the examination results of patients' biological samples. The outcome of follow-up was defined as patients having been followed up for five years, or having a patient lost to follow-up or dying during follow-up.

Conditions

• Biliary Tract Diseases
• Gallbladder Cancer
• Gallbladder Neoplasms

Interventions

Type	Name	Description
OTHER	no interventions	retrospective registry cohort with no other specific interventions

Timeline

• Start date: 2024-03-01
• Primary completion: 2027-02-28
• Completion: 2029-02-28
• First posted: 2024-02-23
• Last updated: 2024-02-28