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

NCT ID: NCT05375370

Last Updated: 2022-05-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2026-09-30

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patient with hepatocellular carcinoma

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

Group Type: EXPERIMENTAL

circulating tumor DNA dosage

Intervention Type: OTHER

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

Interventions

circulating tumor DNA dosage

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edouard ROUSSEL, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Central Contacts

Edouard ROUSSEL, MD

Role: CONTACT

edouard.roussel@chu-rouen.fr

+3323288 ext. 8610

Julie RONDEAUX

Role: CONTACT

julie.rondeaux@chu-rouen.fr

+3323288 ext. 5427

Other Identifiers

2020/0414/OB

Identifier Type: -

Identifier Source: org_study_id