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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Other: circulating tumor DNA dosage

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edouard ROUSSEL, MD; Phone Number: 8610 +3323288; Email: edouard.roussel@chu-rouen.fr
• Study Contact Backup: Name: Julie RONDEAUX; Phone Number: 5427 +3323288; Email: julie.rondeaux@chu-rouen.fr

Study Locations

• France
  • Rouen, France, 76031
    • Recruiting
    • CHU Rouen
    • Contact: Edouard Roussel, Dr
    • Principal Investigator: Edouard Roussel, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient with hepatocellular carcinoma; Circulating tumor DNA dosage will be done to patients with hepatocellular carcinoma	Other: circulating tumor DNA dosage; blood sample for circulating tumor DNA dosage will be done to patient with hepatocellular carcinoma

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Edouard ROUSSEL, MD, University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2022
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: biomarker; ctDNA
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: 2020/0414/OB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No