Construction of Multicenter Retrospective Registry Cohort Database for Gallbladder Cancer

NCT ID: NCT06276153

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2029-02-28

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Gallbladder cancer

Diagnostic criteria:

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.

no interventions

Intervention Type: OTHER

retrospective registry cohort with no other specific interventions

Interventions

no interventions

retrospective registry cohort with no other specific interventions

Intervention Type: OTHER

Eligibility Criteria

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 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.
• Karnofsky performance score greater than 50.

Exclusion Criteria

• 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.
• The patient is participating in other therapeutic clinical trials where treatment measures cannot be clarified or treatment information cannot be collected .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Liu Ying-bin

Director of Pancreato-biliary Surgery, Principal Investigator, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ying-Bin Liu, PhD.

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Central Contacts

Xu-Heng SUN, PhD.

Role: CONTACT

sunxh96@sjtu.edu.cn

+8619117209107

Yi-Jun Wang, MD.

Role: CONTACT

wangyijun1998@sjtu.edu.cn

+8618521757838

Other Identifiers

CRGGCext

Identifier Type: -

Identifier Source: org_study_id