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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    CHU de Rouen

    Rouen, France, 76031