Cohort Study of Patients With Hepatocellular Carcinoma and Circulating Tumor DNA Monitoring of Chemoembolization (Mona-Lisa)

Cohort study to assess the impact of ctDNA detection in the follow-up and management of patients with hepatocellular carcinoma treated by TACE

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma Non-resectable; Circulating Tumor DNA; Transarterial Chemoembolization
• Intervention / Treatment: Biological: DNA

Detailed Description

The incidence of hepatocellular carcinoma (HCC) has increased significantly over the past 30 years.

The majority of HCCs present at an intermediate stage, ineligible for a curative surgical approach and the reference treatment in this situation corresponds to a palliative locoregional treatment of Transarterial chemoembolization (TACE). This treatment modality can be repeated several times and the interval between each session as well as the modalities to evaluate the efficacy of this procedure remain poorly codified. This evaluation is currently based on imaging performed at one month (M1) (MRI and/or CT scan) more or less associated with the study of the variation of the alphafetoprotein level measured before (baseline) and after (M1) the treatment. However, these evaluation tools have many limitations and remain imperfect in predicting response to treatment.

In this context, liquid biopsy, which is experiencing significant growth in oncology, could be a promising tool. It is characterized by the detection of tumor elements in the bloodstream such as circulating tumor DNA (ctDNA). Several studies have successfully demonstrated the diagnostic or prognostic value of ctDNA in patients followed for HCC.

the aim of our study is to evaluate the impact of ctDNA detection in the follow-up of patients treated by TACE.

• Study Type: Observational
• Enrollment (Anticipated): 167

Contacts and Locations

• Study Contact: Name: Vincent Verdier, MD; Phone Number: +33 2 32 88 86 10; Email: vincent.verdier@chu-rouen.fr

Study Locations

• France
  • Rouen, France, 76031
    • Recruiting
    • CHU de Rouen
    • Contact: Vincent Verdier, MD; Phone Number: +33 2 32 88 86 10; Email: vincent.verdier@chu-rouen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

• Patient with a first TACE (naive) or not, regardless of the number of previous procedures
• Patient naïve or on a new line of oncological treatment, regardless of the number of previous lines of treatment.

Description

Inclusion Criteria:

• Age ≥ 18 years
• HCC diagnosed on consensus radiological criteria in cirrhotic patients (EASL-EORTC 2012): helical CT or MRI with triple arterial, portal, and late acquisition. The diagnosis is based on the presence of hypervascularization at the early arterial time (wash-in) with wash-out (hypodensity or hypointensity compared with non-tumor liver parenchyma) at the portal phase or late phase compared with non-tumor parenchyma.
• Histologically diagnosed HCC in the absence of an imaging diagnosis
• Patient with a first TACE (naive) or not, regardless of the number of previous procedures
• Patient naïve or on a new line of oncological treatment, regardless of the number of previous lines of treatment.
• Treatment decision validated by the digestive oncology staff.
• Patient having read and understood the information letter and signed the informed consent.
• Patient follow-up performed at the Charles Nicolle University Hospital in Rouen.

Exclusion Criteria :

• Other active cancer or hematological malignancy, currently being treated
• Patient not affiliated to the social security system
• Pregnant woman or woman in labour or breastfeeding
• Person deprived of liberty by an administrative or judicial decision
• Person placed under court protection

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological response at 1 month according to mRECIST and ctDNA detection	radiological response : mRECIST (progressive disease; stable disease, partial response, complete response) LIRADS (LR-TR Nonviable, LR-TR Equivocal, LR-TR Viable); ctDNA at 1 month detection (yes or no)	4 to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival and overall survival	progression-free Survival and overall Survival (months)	4 to 6 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Vincent VERDIER, MD, vincent.verdier@chu-rouen.fr

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: cell-free DNA; circulating tumor DNA; hepatocellular carcinoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: 2019/330/OB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No