Hepatocellular Carcinoma
Conditions
Keywords
ctDNA, biomarker
Brief summary
The goal of the REMNANT study is to confirm the clinical value of detecting a new biomarker, ctDNA (circulating tumor DNA), in the follow-up of patients with operated liver cancer. In order to meet this objective, this biomarker will be measured in your blood before and after surgery, at three and six months.
Detailed description
Hepatocellular carcinoma (HCC) is the most common primary liver cancer and develops in 80% of cases in the context of underlying cirrhosis1. Surgical resection, percutaneous destruction and liver transplantation are the three treatments considered curative with a non-negligible risk of recurrence of 35-50% at 2 years2. Several data in the literature suggest that small subclinical tumors can be detected by circulating tumor DNA (ctDNA), and that the amount of tcDNA detected seems to correlate with risk factors for recurrence such as tumor size or microvascular invasion3, 4. The objective of this pilot study is to evaluate the detection of ctDNA following tumor ablation and its impact on early recurrence.
Interventions
OTHERcirculating tumor DNA dosage
blood sample for circulating tumor DNA dosage will be done to patient with hepatocellular carcinoma
Sponsors
University Hospital, Rouen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. 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 to non-tumor liver parenchyma) at the portal phase or late phase compared to non-tumor parenchyma. 3. HCC diagnosed histologically in the absence of a diagnosis on imaging (see IC n°2 above) 4. Patient operated on for liver resection or radiofrequency destruction 5. Treatment decision validated by the digestive oncology PCR 6. Patient having read and understood the information letter and signed the non-opposition form 7. Patient follow-up at the Charles Nicolle University Hospital in Rouen
Exclusion criteria
1. Other active cancer or hematological malignancy 2. Contra-indication to surgery 3. Patient not affiliated to the social security system 4. Pregnant woman or parturient or breastfeeding 5. Person under court protection, sub guardianship or curatorship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in tcNA dosage between baseline and 6 Months | 6 months | evolution of tcDNA percentage between Baseline and at 6 months after surgery |
| Change in tcDNA dosage between baseline and 3 Months | 3 months | evolution of tcDNA percentage between Baseline and at 3 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival at 2 years | 2 years | percentage of Survival 2 years after surgery |
Countries
France
Contacts
CONTACTEdouard ROUSSEL, MD
CONTACTJulie RONDEAUX
PRINCIPAL_INVESTIGATOREdouard ROUSSEL, MD
University Hospital, Rouen
Outcome results
None listed