Clinical trial NCT05235490: Identification of Image Phenotypes to Predict Recurrence After Resection of Hepatocellular Carcinoma
Official title: Identification of Image Phenotypes to Predict Recurrence After Resection of Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CT Scans Prior to Surgery With a Least 2 Years of Follow-up
Keywords: Hepatocellular Carcinoma
Hepatic resection
Biomarkers from CT scan
Prognostic value
Early recurrence with hepatocellular cancer patients
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Median Technologies
First posted: 2022-02-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data of patients who has hepatectomy (resection R0) for an HCC treatment will be collected from January 2011 to December 2019.

Brief summary: Tumor recurrence, which occurs in 70% of patients with HCC within 5 years after hepatic resection, is a major cause of post-resection-death. This recurrence can be true recurrence (intrahepatic metastases), which occurs sooner than 2 years later, or it can be due to the development of de-novo tumors at least 2 years later. Despite this high rate of tumor recurrence, no anti-recurrence adjuvant therapies are currently recommended.

Imaging phenomics is the systematic, large scale extraction of imaging features for the characterization and classification of disease phenotypes. Combining imaging and tissue phenomics could be a solution to predict HCC recurrence. With the emergence of molecular therapies and immunotherapies, identifying patients with HCC at high risk of post-resection recurrence would help determine additional therapeutic and management strategies in clinical practice.

Detailed description: Hepatocellular carcinoma (HCC) is among the most lethal and prevalent cancers in the human population and it is now the third leading cause of cancer deaths worldwide, with over 500,000 people affected. Because of the high recurrence rate after curative hepatectomy, accurate prognostic assessment in HCC patients are quite important. With the emergence of molecular therapies and immunotherapies, the identification of patients at high or low risk for recurrence after hepatic resection would help determine additional therapeutic and management strategies in clinical practice. Although many immunohistochemical markers have been reported to have a prognostic value for HCC patients, there is no consensus on how these markers could add prognostic value to the clinical parameters.

In the initial step of biomarker discovery, no specific sample size is provided, however to test hypothesis, 100 patients are required.

This first study will potentially be followed by a second similar study promoted by the same investigators to increase the statistical power to improve the classification tool according to the patient's future.

Period covered by the data collection: 2011-2019 / Duration data collection: 1 year.

The primary endpoint will be built using machine learning method to obtain prediction of recurrence within 2 years. The Recurrence Free survival (RFS) within two years will be the reference outcome to evaluate the prognostic of the patients.

The secondary endpoint are following :

- A secondary endpoint which will be built using machine learning method to obtain prediction of recurrence after 2 years.

The Recurrence Free survival (RFS) after two years will be the reference outcome to evaluate the prognostic of the patients.

- A secondary endpoint will be the correlation between biomarker from CT scan and pathological biomarkers As the spectrum of HCC disease is very large, many patients to conduct conclusive validation studies for diagnostic and prognostic relevance need to be obtained.

Overall, each specific-read out endpoint will include a sample size calculation and - if appropriate - a power analysis specific to the objective of this study.

During training, phenotyping system performance assessment will be done to guide the calculation of the sample size for the validation.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Patients who underwent surgery and have R0 resection after 2010
* Multiphase CT scans with contrast media should be performed within 2 months prior to surgical intervention
* At least 2 years of follow-up data on intrahepatic recurrence

Exclusion Criteria:

* Previous HCC treatment
* Combination of other anti-cancer treatment
* Other malignancies
* Patient expressly expressing opposition to the exploitation of their data as defined by the project
* Protected adults

Primary outcomes:
measure: The main objective of this work is to identify biomarkers from CT scan (non-invasive imaging phenotypes from radiological images) which have a prognostic value for an early recurrence in patients with hepatocellular cancer.
timeFrame: 2 years
Secondary outcomes:
measure: Identify biomarkers from CT scan (non-invasive imaging phenotypes from radiological images) which have a prognostic value for a tardive recurrence in patients with hepatocellular cancer.
timeFrame: 2 years
Other outcomes:
measure: To correlate the imaging signatures predictive of recurrence with the cell population molding of tissue microenvironment (TME) and the tumor biology using tissue assessment as reference.
timeFrame: 1 year
Locations:
city: Villejuif
country: France
facility: Paul Brousse Hospital
Study officials:
affiliation: Paul Brousse Hospital
name: Maïté LEWIN, Professor
role: PRINCIPAL_INVESTIGATOR
References: