Clinical trial · Observational
Artificial Intelligence and Hepatocellular Carcinoma
NCT05637788CI-TRIAL-00074651ARTIHCCunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To identify new relevant biomarkers for HCC patients and their risk of recurrence. Radiomics data and computer-vision data will be explored for their ability to predict the presence of particular pathological signs of aggressiveness (microvascular invasion and satellitosis), and the prognosis after surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HCC | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT Scan Radiomics Features Extraction | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HCC Patients Submitted Surgery
- description
- For the retrospective data collection, the planned number of subjects that will be enrolled will be almost 150/year. Considering the study-period (2010-2020), it is estimated a total of 1500 patients. For the prospective observational data collection, the estimation of patients'enrolment is based on the number of patients treated per year in the participating centers (globally 150/year). Since the observational nature, patients will be evaluated for their enrolment consecutively. The prospective data collection will be prosecuted for 2 years, leading to a prospective cohort of 300 patients. The whole study is planned to be ended in December 2023. Inclusion and exclusion criteria will be the same among the retrospective and the prospective parts of the study.
- interventionNames
- Diagnostic Test: CT Scan Radiomics Features Extraction
Primary outcomes (1)
- measure
- Evaluate the association between different radiomics and computer-vision features, and the survival after surgery
- timeFrame
- 1 Year and 4 Months
- description
- Evaluate the association between different radiomics (obtained by the pre-operative CT scans) and computer-vision (obtained by the photos of the remnant liver after surgery) features, and the survival after surgery (in terms of Recurrence-Free Survival and Overall Survival). Thus, to develop a prediction algorithm based on that features.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>= 18 years old. * Hepatocarcinoma diagnosis confirmed at histological specimen * Being at the first HCC diagnosis or with a recurrence/persistence disease evaluated and treated for the first time with surgery at the participating center. * Available contrast-enhanced CT Scan obtained no more than 1 month prior to surgery. Exclusion Criteria: * Surgery as a downstaging therapy for transplant * Patients treated with surgery in case of not-curative intent (palliation, best supportive care, etc). * Histopathological specimen of combined liver primary neoplasms (e.g. 'epatocolangiocarcinoma').
References
Publications (0)
Data not yet available
No reference posted for this study.