Construction of Multicenter Retrospective Registry Cohort Database for Gallbladder Cancer (CRGGCext)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Biliary Tract Diseases; Gallbladder Neoplasms; Gallbladder Cancer
• Intervention / Treatment: Other: no interventions

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.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Xu-Heng SUN, PhD.; Phone Number: +8619117209107; Email: sunxh96@sjtu.edu.cn
• Study Contact Backup: Name: Yi-Jun Wang, MD.; Phone Number: +8618521757838; Email: wangyijun1998@sjtu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study 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.

Description

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 .

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: no interventions; retrospective registry cohort with no other specific interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From date of enrollment until the date of death from any cause, whichever came first, assessed up to 5-years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From date of enrollment until the date of first documented progression from any cause, whichever came first, assessed up to 5-years.

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Principal Investigator: Ying-Bin Liu, PhD., RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: February 18, 2024
• First Submitted That Met QC Criteria: February 18, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 25, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: cohort study; biliary tract neoplasms; gallbladder cancer; gallbladder neoplasms; registry cohort
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Digestive System Neoplasms; Gallbladder Diseases; Biliary Tract Neoplasms; Neoplasms; Gallbladder Neoplasms; Biliary Tract Diseases
• Other Study ID Numbers: CRGGCext

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No