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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorTian'an Jiang

About this trial

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 criteria

Qualifiers

① Diagnosed as primary HCC according to the diagnostic criteria for primary liver cancer in China; ② Either a solitary tumor with a diameter less than 5 cm or 2-3 tumors each with a maximum diameter less than 3 cm; ③ RFA as the initial treatment; ④ Agreed to participate in the study and submitted the completed questionnaire survey; ⑤ A follow-up period exceeding 6 months after ablation.

Disqualifiers

① Vascular invasion or extrahepatic metastasis before ablation; ② Presence of intractable ascites or hepatic encephalopathy; ③ Severe hepatic and renal dysfunction or other substantial organ disorders; ④ Active infections before or after ablation; ⑤ A history of other malignancies; ⑥ Failure to submit a completed questionnaire survey; ⑦ Lost to follow-up before reaching an outcome.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

6,000 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Tian'an Jiang

Lead sponsor

First Affiliated Hospital of Zhejiang University

Sponsor institution