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

NCT05375370 | Recruiting

• 1 other identifier: 2020/0414/OB
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

ctDNA; biomarker

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Survival at 2 years

  2 years

Study Arms (1)

Patient with hepatocellular carcinoma

EXPERIMENTAL

Circulating tumor DNA dosage will be done to patients with hepatocellular carcinoma

Other: circulating tumor DNA dosage

Interventions

circulating tumor DNA dosage OTHER

blood sample for circulating tumor DNA dosage will be done to patient with hepatocellular carcinoma

Patient with hepatocellular carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Chu Rouen

Rouen, 76031, France

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Edouard ROUSSEL, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edouard ROUSSEL, MD

CONTACT

+3323288; edouard.roussel@chu-rouen.fr

Julie RONDEAUX

CONTACT

+3323288; julie.rondeaux@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 16, 2022
• Study Start: August 4, 2022
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)