- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06861114
Exploring the Value of Urine Proteomics-based Dynamic Surveillance for Early Recurrence After Radical Surgery for Hepatocellular Carcinoma: a Prospective Cohort Study
March 2, 2025 updated by: Mingxin Pan, Zhujiang Hospital
In this study, we explored and validated the predictive value of the longitudinal monitoring model of urinary proteomics for postoperative recurrence of hepatocellular carcinoma and the predictive value of minimal residual disease (MRD) status, verified whether it is earlier than the recurrence suggested by imaging tests, and initially explored its clinical feasibility in guiding the adjuvant treatment of hepatocellular carcinoma in the postoperative period, so as to provide a new idea for the strategy of early intervention in the postoperative period of hepatocellular carcinoma.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
38
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
-
-
Guangdong
-
Guangzhou, Guangdong, China
- Recruiting
- Zhujiang Hospital of Southern Medical University
-
Contact:
- zhujiang hospital
- Phone Number: +86-020-61643888
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with hepatocellular carcinoma whose tumor stage at the time of initial diagnosis is consistent with BCLC staging 0/stage A/stage B, who can undergo radical surgical resection, and who have not received other antitumor therapy preoperatively.
Description
Inclusion Criteria:
- Patients with hepatocellular carcinoma whose tumor stage at the time of initial diagnosis is consistent with BCLC staging 0/stage A/stage B, who can undergo radical surgical resection, and who have not received other antitumor therapy preoperatively.
Exclusion Criteria:
- Unable to provide specimens for testing such as urine proteomics; patients with a previous diagnosis of renal or urologic disease, two or more tumors at the same time; patients with non-primary foci of liver disease. Previously received anti-tumor therapy such as targeted immunotherapy.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
2-year relapse-free survival
Time Frame: 2-year
|
2-year
|
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)
February 20, 2025
Primary Completion (Estimated)
December 20, 2027
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
March 2, 2025
First Submitted That Met QC Criteria
March 2, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 2, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-KY-046-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.
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