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Trial Title:
Primary Hepatobiliary Cancer Cohort of Central China
NCT ID:
NCT05520801
Condition:
Hepatocellular Carcinoma
Biliary Tract Neoplasms
Conditions: Official terms:
Biliary Tract Neoplasms
Conditions: Keywords:
Primary Hepatobiliary Cancer
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Other
Summary:
This registry is designed as a longitudinal cohort study of patients diagnosed with
primary hepatobiliary cancer in Tongji Hospital, Wuhan. This study collects the
clinical-pathological features of hepatic malignant tumors and the current status of
patients who received comprehensive treatment based on surgical treatment since 1998.
Detailed description:
This longitudinal observational cohort study was designed to make standardized
settlements, statistical treatments, and comprehensive analysis of primary hepatobiliary
cancers in middle China, which summarize and estimate the population, tumor staging,
treatment mode, clinical-pathological characteristics, and the prognosis, to provide
evidence for standardized treatment of hepatobiliary cancers.
Criteria for eligibility:
Study pop:
Patients who diagnosed as primary hepatobiliary cancer.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. ≥18 years old,
2. life expectancy is at least 6 months.
3. Diagnosed as primary liver cancer or biliary malignant tumor by histopathology or
confirmed by imaging as HCC (by the AASLD or guidance for the diagnosis and
treatment of primary liver cancer of China (version 2022).
4. At least one measurable lesion (RECIST v1.1)
5. Subjects volunteer to participate in the study and sign informed consent.
Exclusion Criteria:
Patients with one or more of the following criteria should be excluded:
1. CT or MRI shows no measurable lesions (RECIST v1.1).
2. Patients after comprehensive assessment are considered by the investigators to be
unsuitable for participating in the study.
3. Incomplete baseline or follow-up data
4. Suffering from more than two kinds of primary tumors
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hepatic Surgery Center, Tongji Hospital, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430030
Country:
China
Status:
Recruiting
Contact:
Last name:
Ze-yang Ding, M.D.
Phone:
+8613407156200
Email:
dingzyang@sina.com
Start date:
May 1, 2020
Completion date:
March 31, 2025
Lead sponsor:
Agency:
Tongji Hospital
Agency class:
Other
Collaborator:
Agency:
Chinese Cooperative Group of Liver Cancer
Agency class:
Other
Collaborator:
Agency:
Chen Xiao-ping Foundation for the Development of Science and Technology of Hubei Province
Agency class:
Other
Collaborator:
Agency:
Haplox Biotechnology Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Geneplus-Beijing Co. Ltd.
Agency class:
Industry
Collaborator:
Agency:
YuceBio Technology
Agency class:
Other
Collaborator:
Agency:
Gelesis, Inc.
Agency class:
Industry
Source:
Tongji Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05520801