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

Primary Purpose

Hepatocellular Carcinoma

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

circulating tumor DNA dosage

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma focused on measuring ctDNA, biomarker

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient with hepatocellular carcinoma

Arm Description

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

Outcomes

Primary Outcome Measures

Change in tcNA dosage between baseline and 6 Months

evolution of tcDNA percentage between Baseline and at 6 months after surgery

Change in tcDNA dosage between baseline and 3 Months

evolution of tcDNA percentage between Baseline and at 3 months after surgery

Secondary Outcome Measures

Survival at 2 years

percentage of Survival 2 years after surgery

Full Information

NCT ID

NCT05375370

First Posted

May 10, 2022

Last Updated

May 16, 2022

Sponsor

University Hospital, Rouen

1. Study Identification

Unique Protocol Identification Number

NCT05375370

Brief Title

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

Acronym

REMNANT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 2022 (Anticipated)

Primary Completion Date

September 2026 (Anticipated)

Study Completion Date

September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Rouen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

ctDNA, biomarker

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patient with hepatocellular carcinoma

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

circulating tumor DNA dosage

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in tcNA dosage between baseline and 6 Months

Description

evolution of tcDNA percentage between Baseline and at 6 months after surgery

Time Frame

6 months

Title

Change in tcDNA dosage between baseline and 3 Months

Description

evolution of tcDNA percentage between Baseline and at 3 months after surgery

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Survival at 2 years

Description

percentage of Survival 2 years after surgery

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Edouard ROUSSEL, MD

Phone

+3323288

Ext

8610

edouard.roussel@chu-rouen.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Julie RONDEAUX

Phone

+3323288

Ext

5427

julie.rondeaux@chu-rouen.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edouard ROUSSEL, MD

Organizational Affiliation

Rouen University Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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