Identification of Image Phenotypes to Predict Recurrence After Resection of Hepatocellular Carcinoma

NCT05235490 | Completed

• 1 other identifier: APHP191113
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  2 years

Secondary Outcomes (1)

• 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.

  2 years

Other Outcomes (1)

• 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.

  1 year

Interventions

Non intervention OTHER

Data study with inclusion of patients and retrospective clinical data collection, combining : * Proofreading by radiologist of the CT scan performed (within 2 months prior to surgical intervention) * Proofreading by iBiopsy® of the CT scan performed (within 2 months prior to surgical intervention) * Proofreading of tumor sample slides by pathologists * Patients follow-up (imaging, clinical) * Recurrence-free survival

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

Data of patients who has hepatectomy (resection R0) for an HCC treatment will be collected from January 2011 to December 2019.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Median Technologies: collaborator

Study Sites (1)

Paul Brousse Hospital

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Officials

• Maïté LEWIN, Professor

  Paul Brousse Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: February 11, 2022
• Study Start: January 28, 2021
• Primary Completion: January 28, 2022
• Study Completion: February 9, 2022
• Last Updated: February 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)