RecruitingNCT06577272

Title of Manuscript: Development and Internal-external Validation of a Comprehensive Model for Predicting Risk of Post-RFA Recurrence in HCC Patients

The First Affiliated Hospital, Zhejiang University School of Medicine


Sponsor

Tian'an Jiang

Enrollment

6,000 participants

Start Date

Sep 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

Background A predictive model for post radiofrequency ablation (RFA) recurrence in patients with Hepatocellular carcinoma (HCC) that incorporates variables like sleep quality and psychological factors can provide more time to prevent the recurrence. Our aim is to investigate the relationship between these factors and post-RFA recurrence, and to construct a predictive model includes these highly preventable factors. Methods We collected data from HCC patients who underwent RFA for the first time from January 1, 2015, to July 2023, assessing their sleep quality, anxiety, and depression levels. We employed Restricted cubic splines (RCS), mediation analysis, Cox proportional hazards model, Elastic network Cox proportional hazards, Competitive risk model to ascertain the relationship between these factors and post-RFA recurrence. We then constructed a predictive model incorporating these factors, and evaluated the model's performance through internal and external validation datasets partitioning by time period.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is building and testing a prediction model that uses patient information to estimate the risk of liver cancer (HCC) coming back after radiofrequency ablation (RFA) — a procedure that uses heat to destroy tumors. The goal is to help doctors better identify who needs closer monitoring after treatment. **You may be eligible if...** - You have been diagnosed with primary liver cancer (HCC) - Your tumor(s) meet certain size criteria (one tumor under 5 cm, or 2–3 tumors each under 3 cm) - You received RFA as your first liver cancer treatment - You have at least 6 months of follow-up data after treatment - You agreed to participate and completed a questionnaire **You may NOT be eligible if...** - Your cancer had spread to blood vessels or outside the liver before treatment - You received other treatments before RFA Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

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NCT06577272


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