Artificial Intelligence and Hepatocellular Carcinoma

NCT05637788 | Active Not Recruiting

• 1 other identifier: ART.I.HCC
• Study Type: observational
• Target: 535
• Locations: 1 country
• Sites: 1

Brief Summary

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

HCC

Keywords

HCC; hepatocellular carcinoma; hepatectomy; liver primary tumor; recurrence; artificial intelligence; machine learning; prognostic prediction; microvascular invasion

Outcome Measures

Primary Outcomes (1)

• Evaluate the association between different radiomics and computer-vision features, and the survival after surgery

  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.

  1 Year and 4 Months

Secondary Outcomes (1)

• Evaluate the association between different radiomics and computer-vision features, and the short-terms results after surgery

  1 Year and 4 Months

Study Arms (1)

HCC Patients Submitted Surgery

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.

Diagnostic Test: CT Scan Radiomics Features Extraction

Interventions

CT Scan Radiomics Features Extraction DIAGNOSTIC_TEST

Extraction of CT radiomics data through AI

HCC Patients Submitted Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by hepatocellular carcinoma (first diagnosis) treated by liver resection.

You may qualify if:

• 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.

You may not qualify if:

• 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').

Sponsors & Collaborators

• Humanitas Clinical and Research Center: lead
• San Gerardo Hospital: collaborator
• Ospedale "Carlo Poma" - Mantova: collaborator
• Ospedale Centrale di Bolzano: collaborator
• University of Pavia: collaborator
• Morgagni Pierantoni Hospital: collaborator
• Regina Elena Cancer Institute: collaborator
• Universita di Verona: collaborator
• University of Milano Bicocca: collaborator
• Treviso Regional Hospital: collaborator
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator
• Miulli General Hospital: collaborator
• Federico II University: collaborator
• Research Institute Against Digestive Cancer IRCAD: collaborator

Study Sites (1)

IRCCS Istituto Clinico Humanitas

Rozzano, Lombardy, 20089, Italy

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Recurrence

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 5, 2022
• Study Start: July 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: November 1, 2025
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)