- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05286099
The Surveillance of Hepatocellular Carcinoma
March 17, 2022 updated by: Ping Liang, Chinese PLA General Hospital
The Surveillance of Development and Progression of Hepatocellular Carcinoma
Early detection of hepatocellular carcinoma is vita to the prognosis of patient.
In this study, the occurrence and development of liver cancer were supervised by imaging examination, and the dysplastic nodules will be distinguished from early hepatocellular carcinoma through macro-imaging and micro-pathological features.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Beijing, China
- Recruiting
- Chinese PLA General Hospital
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Contact:
- Jie Yu
- Phone Number: 8601066939530
- Email: jiemi301@163.com
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Beijing
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Beijing, Beijing, China, 100853
- Recruiting
- Chinese PLA General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with hepatitis B, liver cirrhosis, or atypical hyperplasia nodules confirmed or suspected by enhanced imaging examination will be enrolled, the contrast-enhanced ultrasound and/or enhanced magnetic resonance imaging will be performed every three months or half a year to observe the size and contrast-enhanced features of the nodules.
If the size or enhancement features change, there will a puncture biopsy under the guidance of ultrasound, and if malignant tumor cells are found, the follow-up will be terminated.
Description
Inclusion Criteria:
- Patients with Hepatitis B and cirrhosis Accept regular imaging examination. Pathological diagnosis of liver cancer.
Exclusion Criteria:
- Can't tolerate the enhanced imaging examination Poor medical compliance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effective detection of early hepatocellular carcinoma
Time Frame: 2 years
|
The occurrence of early hepatocellular carcinoma
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2022
Primary Completion (Anticipated)
July 1, 2023
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
February 22, 2022
First Submitted That Met QC Criteria
March 17, 2022
First Posted (Actual)
March 18, 2022
Study Record Updates
Last Update Posted (Actual)
March 18, 2022
Last Update Submitted That Met QC Criteria
March 17, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S2022-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.