Clinical Trials Directory

Trials / Unknown

UnknownNCT05390112

Cohort Study of Patients With Hepatocellular Carcinoma and Circulating Tumor DNA Monitoring of Chemoembolization

Status
Unknown
Phase
Study type
Observational
Enrollment
167 (estimated)
Sponsor
University Hospital, Rouen · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALDNActDNA; cfDNA

Timeline

Start date
2021-05-20
Primary completion
2024-06-30
Completion
2024-12-31
First posted
2022-05-25
Last updated
2022-05-25

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05390112. Inclusion in this directory is not an endorsement.