Status:
UNKNOWN
Cohort Study of Patients With Hepatocellular Carcinoma and Circulating Tumor DNA Monitoring of Chemoembolization
Lead Sponsor:
University Hospital, Rouen
Conditions:
Circulating Tumor DNA
Hepatocellular Carcinoma Non-resectable
Eligibility:
All Genders
18+ years
Brief Summary
Cohort study to assess the impact of ctDNA detection in the follow-up and management of patients with hepatocellular carcinoma treated by TACE
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 20 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT05390112
Start Date
May 20 2021
End Date
December 31 2024
Last Update
May 25 2022
Active Locations (1)
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1
CHU de Rouen
Rouen, France, 76031