Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Monitoring Circulating Tumor DNA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: circulating tumor DNA dosage.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Monitoring Circulating Tumor DNA: a Prospective Cohort Study
Overview
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
- Other circulating tumor DNA dosage
blood sample for circulating tumor DNA dosage will be done to patient with hepatocellular carcinoma
Primary outcome measures
- Change in tcNA dosage between baseline and 6 Months [Time frame: 6 months]
- Change in tcDNA dosage between baseline and 3 Months [Time frame: 3 months]
Secondary outcome measures (1)
- Survival at 2 years [Time frame: 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Chu Rouen — Rouen
Identifiers
NCT: NCT05375370 · 2020/0414/OB