Clinical trial · Observational

The Construction of Clinical Database and Multiomics Biobank Based on a Multicentral Prospective Cohort of Benign and Malignant Biliary Tract Diseases

The Construction of Clinical Database and Multiomics Biobank Based on a Multicentral Prospective Cohort of Benign and Malignant Biliary Tract Diseases 胆道系统良恶性肿瘤前瞻性登记队列数据库与多组学生物样本库建设

NCT05896956CI-TRIAL-00067051not yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The aim of the study is to establishing a standardized biobank and a clinical information database for patients with benign and malignant tumors of the biliary system. With follow-up plans and advanced multiomics technology, a multiomics database for patients with benign and malignant tumors of the biliary tract will be further established. Based on the above work, 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 based on multiomics characteristics and molecular typing of biliary tract tumors.

Conditions

Conditions (6)

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	—
Biliary Tract Neoplasms	—	UNRESOLVED	—
Extrahepatic Bile Duct Cancer	Malignant Extrahepatic Bile Duct Neoplasm	ALIAS	0.90
Gallbladder Cancer	Malignant Gallbladder Neoplasm	CURATED_EXACT	0.92
Gall Stone	—	UNRESOLVED	—
Intrahepatic Cholangiocarcinoma	Intrahepatic Cholangiocarcinoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
no interventions	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

label
Patients with benign or malignant tumors of the biliary system
description
Patients enrolled should be clinically diagnosed with benign or malignant tumors of the biliary system, including unoperated patients with preliminary diagnosis of benign or malignant tumors of the biliary tract based on imaging examinations and laboratory test results, or pathological examination of patients treated with surgery confirmed as benign and malignant tumors of the gallbladder; The primary tumor is located in the extrahepatic bile ducts, intrahepatic bile ducts, gallbladder floor, gallbladder body, gallbladder neck, or gallbladder duct.
interventionNames
1. Other: no interventions

Primary outcomes (1)

measure
overall survival
timeFrame
The last follow-up ended with the first of all patients followed up to death, loss to follow-up or withdrawal of informed consent, or follow-up for 2 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.

Eligibility

Eligibility (as posted)

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

Show eligibility criteria text

Inclusion Criteria:

1. Sign informed consent, have good compliance, and be willing to accept follow-up and provide blood samples.
2. Age 18-74 years old, gender is not limited.
3. Clinical diagnosis of benign and malignant tumors of the biliary system, including unoperated patients preliminarily diagnosed as benign and malignant tumors of the biliary tract according to the results of imaging examinations and laboratory tests, or pathological examination of patients treated with surgery confirmed as benign and malignant tumors of the gallbladder.
4. The primary tumor is located in the extrahepatic bile duct, intrahepatic bile duct, gallbladder floor, gallbladder body, gallbladder neck or gallbladder duct.
5. Karnofsky performance score greater than 50.

Exclusion Criteria:

1. Patients with biliary malignant tumors, biliary malignant tumor foci are not primary lesions.
2. Patients with biliary malignant tumors, 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.
3. Patients with biliary malignant tumors, 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.
4. Patients with biliary malignant tumors, women of childbearing age who have a positive blood pregnancy test or have not had a pregnancy test, pregnant or breastfeeding women.
5. 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.