Construction of Multicenter Retrospective Registry Cohort Database for Gallbladder Cancer

NCT06276153 | Not Yet Recruiting

• 1 other identifier: CRGGCext
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Biliary Tract Diseases; Gallbladder Cancer; Gallbladder Neoplasms

Keywords

gallbladder cancer; gallbladder neoplasms; cohort study; registry cohort; biliary tract neoplasms

Outcome Measures

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.

  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

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

Study Arms (1)

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

Interventions

no interventions OTHER

retrospective registry cohort with no other specific interventions

Gallbladder cancer

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• RenJi Hospital: lead

MeSH Terms

Conditions

Biliary Tract Diseases; Gallbladder Neoplasms; Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Gallbladder Diseases

Study Officials

• Ying-Bin Liu, PhD.

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu-Heng SUN, PhD.

CONTACT

+8619117209107; sunxh96@sjtu.edu.cn

Yi-Jun Wang, MD.

CONTACT

+8618521757838; wangyijun1998@sjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pancreato-biliary Surgery, Principal Investigator, Professor

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: February 23, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2029
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share