Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Monitoring Circulating Tumor DNA

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Monitoring Circulating Tumor DNA: a Prospective Cohort Study

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Other: circulating tumor DNA dosage


Participation Criteria
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Eligibility Criteria
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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 to non-tumor liver parenchyma) at the portal phase or late phase compared to non-tumor parenchyma. HCC diagnosed histologically in the absence of a diagnosis on imaging (see IC n°2 above) Patient operated on for liver resection or radiofrequency destruction Treatment decision validated by the digestive oncology PCR Patient having read and understood the information letter and signed the non-opposition form Patient follow-up at the Charles Nicolle University Hospital in Rouen Exclusion Criteria: Other active cancer or hematological malignancy Contra-indication to surgery Patient not affiliated to the social security system Pregnant woman or parturient or breastfeeding Person under court protection, sub guardianship or curatorship

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with hepatocellular carcinoma<br>Circulating tumor DNA dosage will be done to patients with hepatocellular carcinoma | Other: circulating tumor DNA dosage<br>* blood sample for circulating tumor DNA dosage will be done to patient with hepatocellular carcinoma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in tcNA dosage between baseline and 6 Months | evolution of tcDNA percentage between Baseline and at 6 months after surgery | 6 months | 
| Change in tcDNA dosage between baseline and 3 Months | evolution of tcDNA percentage between Baseline and at 3 months after surgery | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival at 2 years | percentage of Survival 2 years after surgery | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ctDNA, biomarker