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

This trial does not accept healthy volunteers

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 population

We identified candidate predictor variables associated with the risk of post-RFA recurrence of HCC patients in clinical or epidemiological literature combined with expert opinion.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

6,000 Participants
are grouped into 2 trial groups
Group A: post-RFA recurrence
Group B: post-RFA did not recurrence

Trial outcomes

Primary outcomes

1

The Self-Rating Anxiety Scale (SAS)24 was used to investigate the anxiety levels of patients

It consists of 20 questions, and the sum of all responses represents the raw total score. The raw total score is multiplied by 1.5 to obtain the standard total score. A standard total score of ≥50 is used to diagnose anxiety. The Self-Rating Depression Scale (SDS)25 was used to assess the depression levels of patients. It also consists of 20 questions, and the sum of all responses represents the raw total score. Similar to the SAS, the raw total score is multiplied by 1.5 to obtain the standard total score. A standard total score of ≥53 is used for diagnosing depression.

Time frame
This study prospectively collected patients diagnosed with HCC from 2015 to 2023 according to the diagnostic criteria in China's guidelines for Primary liver Cancer Diagnosis and Treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

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Tian'an Jiang

Lead sponsor

First Affiliated Hospital of Zhejiang University

Sponsor institution