Clinical trial · Observational

Construction of Multicenter Retrospective Registry Cohort Database for Gallbladder Cancer

NCT06276153CI-TRIAL-00074397CRGGCextnot yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Biliary Tract Diseases	—	UNRESOLVED	—
Gallbladder Cancer	Malignant Gallbladder Neoplasm	CURATED_EXACT	0.92
Gallbladder Neoplasms	Gallbladder Neoplasm	ONTOLOGY_EXACT	0.98

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
no interventions	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

label
Gallbladder cancer
description
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.
interventionNames
1. Other: no interventions

Primary outcomes (1)

measure
overall survival
timeFrame
From date of enrollment until the date of death from any cause, whichever came first, assessed up to 5-years.
description
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.

Secondary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 74 Years

Show eligibility criteria text

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 .

References

Publications (0)

Data not yet available

No reference posted for this study.