HCCARTIHCCNCT05637788
Artificial Intelligence and Hepatocellular Carcinoma
An observational study of HCC, run by Humanitas Clinical and Research Center at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC
- What is being tested?
- CT Scan Radiomics Features Extraction
- How many people
- 535 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2021to 1 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by hepatocellular carcinoma (first diagnosis) treated by liver resection.
Who may be able to join
- 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.
Who cannot join
- 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').
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Hepatocellular carcinoma (HCC) is 1 of the 5 most common malignancies worldwide and the third most common cause of cancer related mortality of 500,000 deaths globally every year.
Although more common in East Asia, the incidence of HCC is increasing in the Western world. Hepatic resection is the first-line therapeutic option, and it is accepted as a safe treatment with a proven impact on prognosis, with a low operative mortality as the result of advances in surgical techniques and perioperative management. Nevertheless, surgical resection is applicable in only about 20% to 30% of patients with HCC, since most have poor hepatic reserve function caused by underlying chronic liver disease and multi focal hepatic distributions of HCC. Although hepatic resection is one of the curative treatments for hepatocellular carcinoma, the recurrence rate of HCC even after curative resection is quite high, estimated to be approximately 50 % during the first 3 years and more than 70 % during the first 5 years after curative resection, and so the postoperative long term results remain unsatisfactory. In this scenario the role of liver transplantation has been, in the last years, predominant, due to the ability of transplant to reduce disease recurrence, because of the treatment of liver cirrhosis associate to HCC which represent the most important driver to recurrence. Otherwise, the scarcity of organ source has been a boost to the spread of liver resection, not only confined in the boundary taken into account in the BCLC algorithm (guidelines endorsed by EASL and AASLD), but even in patients considered not suitable for curative treatment as well as liver resection. Although surgical treatment has been adopted in the last years in more patients outside the Guidelines with satisfactory results in terms of mortality, morbidity and Short term oncological outcomes, the limits of this approach remain the long term disease free survival.
Risk factor for recurrence has been yet identified in the last years as hcc dimension, grading, microvascular invasion and satellitosis. The evidence that these two prognostic factors could negatively impact on the long term prognosis enhancing the risk of recurrence, has led many Author to propose anatomical resection (segmental resection) as the ideal surgical treatment to reduce these risks in HCC patients. Otherwise, literature results are in conflict regarding the real benefit of this approach. In fact in many patients with HCC and underlying cirrhosis the anatomical approach is not feasible due to the risk of postoperative liver failure. So a parenchyma-sparing technique has been developed and compared to anatomical resection in terms of oncological outcomes. At the present, all these risk factors are not predictable, and the staging systems are based only on crude radiological features as the number and the size of the nodules. In the recent years, several authors proposed new approaches to increase our ability to extract data from the radiological imaging: by the analysis of the measurements and numbers obtained during the radiological acquisition (by CT or MRI scans), thousands of other information are obtainable, overcoming the ability of human eyes. Those techniques go under the names of "Radiomics", which is a very promising branch when merged with the novel machine learning algorithms (e.g. Deep Learning, Neural Networks, etc). Moreover, nowadays, novel data can be obtained also by simple intraoperative photo obtained during the surgical procedure, for example of the liver cut surface: by the "computer-vision analysis", another powerful machine-learning algorithm, other data can be produced to predict short and long term outcomes. Those potentialities rely on the modern field of "artificial intelligence", where a machine is trained to recognize different recurrent patterns to create prediction models with a very powerful accuracy. On these data is based the proposal to create the present multicentric study with the aim to develop a prediction model for post-operative complications and HCC recurrence, based on the analysis of CT-radiomics features, liver cut surface photos and machine learning analysis.
- Conditions
- HCC
- Being tested
- CT Scan Radiomics Features Extraction
- Keywords
- HCC, hepatocellular carcinoma, hepatectomy, liver primary tumor, recurrence, artificial intelligence, machine learning, prognostic prediction, microvascular invasion
- Medical subject headings
- Carcinoma, Hepatocellular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT Scan Radiomics Features ExtractionDiagnostic test
Extraction of CT radiomics data through AI
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: CT Scan Radiomics Features Extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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 short-terms results after surgery (complications, biliary fistula, severity, 90-day mortality, presence of microvascular invasion and satellitosis).
Measured: 1 Year and 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Jul 2021
- Primary completion1 Jan 2022
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 535 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanitas Clinical and Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- San Gerardo Hospital, Ospedale "Carlo Poma" - Mantova, Ospedale Centrale di Bolzano, University of Pavia, Morgagni Pierantoni Hospital, Regina Elena Cancer Institute, Universita di Verona, University of Milano Bicocca, Treviso Regional Hospital, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Miulli General Hospital, Federico II University, Research Institute Against Digestive Cancer IRCAD
- Responsible party
- Principal investigator, Simone Famularo, MD, Humanitas Clinical and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637788
- Sponsor's protocol ID
- ART.I.HCC
- Acronym
- ARTIHCC
- Status last verified
- Mar 2024
- First submitted
- 21 Nov 2022
- Last updated
- 4 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Agreggated Data
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence and Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05637788
- Acronym / sponsor ID
- ARTIHCC / ART.I.HCC
- Conditions
- HCC
- Keywords
- HCC, hepatocellular carcinoma, hepatectomy, liver primary tumor, recurrence, artificial intelligence, machine learning, prognostic prediction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 535 participants (actual)
- Lead sponsor
- Humanitas Clinical and Research CenterUniversity, hospital or other
- Collaborators
- San Gerardo Hospital, Ospedale "Carlo Poma" - Mantova, Ospedale Centrale di Bolzano, University of Pavia, Morgagni Pierantoni Hospital, Regina Elena Cancer Institute, Universita di Verona, University of Milano Bicocca, Treviso Regional Hospital, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Miulli General Hospital, Federico II University, Research Institute Against Digestive Cancer IRCAD
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hepatocellular carcinoma (HCC) is 1 of the 5 most common malignancies worldwide and the third most common cause of cancer related mortality of 500,000 deaths globally every year.
Although more common in East Asia, the incidence of HCC is increasing in the Western world. Hepatic resection is the first-line therapeutic option, and it is accepted as a safe treatment with a proven impact on prognosis, with a low operative mortality as the result of advances in surgical techniques and perioperative management. Nevertheless, surgical resection is applicable in only about 20% to 30% of patients with HCC, since most have poor hepatic reserve function caused by underlying chronic liver disease and multi focal hepatic distributions of HCC. Although hepatic resection is one of the curative treatments for hepatocellular carcinoma, the recurrence rate of HCC even after curative resection is quite high, estimated to be approximately 50 % during the first 3 years and more than 70 % during the first 5 years after curative resection, and so the postoperative long term results remain unsatisfactory. In this scenario the role of liver transplantation has been, in the last years, predominant, due to the ability of transplant to reduce disease recurrence, because of the treatment of liver cirrhosis associate to HCC which represent the most important driver to recurrence. Otherwise, the scarcity of organ source has been a boost to the spread of liver resection, not only confined in the boundary taken into account in the BCLC algorithm (guidelines endorsed by EASL and AASLD), but even in patients considered not suitable for curative treatment as well as liver resection. Although surgical treatment has been adopted in the last years in more patients outside the Guidelines with satisfactory results in terms of mortality, morbidity and Short term oncological outcomes, the limits of this approach remain the long term disease free survival.
Risk factor for recurrence has been yet identified in the last years as hcc dimension, grading, microvascular invasion and satellitosis. The evidence that these two prognostic factors could negatively impact on the long term prognosis enhancing the risk of recurrence, has led many Author to propose anatomical resection (segmental resection) as the ideal surgical treatment to reduce these risks in HCC patients. Otherwise, literature results are in conflict regarding the real benefit of this approach. In fact in many patients with HCC and underlying cirrhosis the anatomical approach is not feasible due to the risk of postoperative liver failure. So a parenchyma-sparing technique has been developed and compared to anatomical resection in terms of oncological outcomes. At the present, all these risk factors are not predictable, and the staging systems are based only on crude radiological features as the number and the size of the nodules. In the recent years, several authors proposed new approaches to increase our ability to extract data from the radiological imaging: by the analysis of the measurements and numbers obtained during the radiological acquisition (by CT or MRI scans), thousands of other information are obtainable, overcoming the ability of human eyes. Those techniques go under the names of "Radiomics", which is a very promising branch when merged with the novel machine learning algorithms (e.g. Deep Learning, Neural Networks, etc). Moreover, nowadays, novel data can be obtained also by simple intraoperative photo obtained during the surgical procedure, for example of the liver cut surface: by the "computer-vision analysis", another powerful machine-learning algorithm, other data can be produced to predict short and long term outcomes. Those potentialities rely on the modern field of "artificial intelligence", where a machine is trained to recognize different recurrent patterns to create prediction models with a very powerful accuracy. On these data is based the proposal to create the present multicentric study with the aim to develop a prediction model for post-operative complications and HCC recurrence, based on the analysis of CT-radiomics features, liver cut surface photos and machine learning analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCC Patients Submitted Surgery | – | Diagnostic Test: CT Scan Radiomics Features ExtractionFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by hepatocellular carcinoma (first diagnosis) treated by liver resection.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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').
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT Scan Radiomics Features ExtractionExtraction of CT radiomics data through AI | Diagnostic test | HCC Patients Submitted Surgery |
Primary outcome
Evaluate the association between different radiomics and computer-vision features, and the survival after surgery
Time frame: 1 Year and 4 Months
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 secondary outcome
Evaluate the association between different radiomics and computer-vision features, and the short-terms results after surgery
Time frame: 1 Year and 4 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No. Agreggated Data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HCC, run by Humanitas Clinical and Research Center at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the association between different radiomics and computer-vision features, and the survival after surgery (time frame: 1 Year and 4 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.