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

NCT06861114 | Recruiting

• 1 other identifier: 2025-KY-046-01
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

urinary proteomics; Hepatocellular carcinoma recurrence after surgery

Outcome Measures

Primary Outcomes (1)

• 2-year relapse-free survival

  2-year

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

urinate

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: March 6, 2025
• Study Start: February 20, 2025
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)