Exploring the Value of Urine Proteomics-based Dynamic Surveillance for Early Recurrence After Radical Surgery for Hepatocellular Carcinoma: a Prospective Cohort Study

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.

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Key information

Conditions

Hepatocellular Carcinoma (HCC) Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

zhujiang hospital

CONTACT

+86-020-61643888

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Urine proteomics

Diagnostic Test

Patients with hepatocellular carcinoma amenable to radical resection were included according to the inclusion exclusion criteria, and preoperative urine and postoperative urine from consecutive patients were collected at the marker time (before receiving postoperative adjuvant therapy after radical surgery for hepatocellular carcinoma) and at the longitudinal time (at the time point of 3 months after radical surgery), and the different samples were preprocessed, followed by mass spectrometry-based urinary proteomics to detect the differences in urinary proteins, and the data were recorded to compare the differences.

Primary outcomes

2-year relapse-free survival

Time frame: 2-year

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Mar 6, 2025
Registry last updated: Mar 6, 2025

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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