NCT07030842Completed
Precision Recurrence Risk Assessment in Early-stage Hepatocellular Carcinoma
Multimodal Deep Learning Models for Predicting Recurrence Pattern in Hepatocellular Carcinoma: A Multicenter Retrospective Development and Validation Study
Source: ClinicalTrials.gov · Last updated 29 Jun 2025
Brief summary (registry, in English)
This retrospective observational study aims to evaluate whether artificial intelligence (AI) models can predict aggressive recurrence in patients who underwent liver resection for early-stage hepatocellular carcinoma (HCC). The main question it seeks to answer is: Can deep learning models combining preoperative MRI, postoperative pathology slides, and clinical data accurately identify HCC patients at high risk of aggressive recurrence after surgery? To answer this, the investigators will analyze existing medical data (preoperative MRIs, postoperative whole-slide images, and clinical records) from 579 patients across two medical centers. All data will be anonymized before analysis, and no additional interventions are required from participants. This study may help clinicians stratify high-risk patients who could benefit from closer surveillance or adjuvant therapies
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 579 (actual)
- First submitted
- 12 Jun 2025
- Start date
- 25 Aug 2023
- Primary completion date
- 30 Jul 2024
- Lead sponsor
- Tongji Hospital
- NCT number
- NCT07030842
What you commit to
- Study type: Observational
- Participants enrolled: 579
- From 25 Aug 2023 to the primary completion date, 30 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- R1/R2 resection (micro/macroscopically positive margins)
- Received neoadjuvant or adjuvant therapy (to avoid treatment confounding)
- Non-curative procedures (e.g., palliative resection)
Other
- Missing or poor-quality preoperative MRI (motion artifacts/insufficient contrast enhancement)
- Incomplete follow-up (loss to follow-up or missing recurrence status)
Who the study is looking for
- Patients who underwent curative liver resection (R0) for pathologically confirmed primary HCC
- BCLC stage 0-A at diagnosis
- Availability of preoperative contrast-enhanced MRI performed within 1 month before surgery
- Availability of postoperative H\&E-stained whole slide images (WSIs) with adequate tumor representation
- Complete clinical follow-up data (minimum 2 years if no recurrence)
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tongji Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.