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

Hepatocellular Carcinoma Clinical Trial

— REMNANT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05375370
• Other study ID #: 2020/0414/OB
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: September 2026

Study information

• Verified date: May 2022
• Source: University Hospital, Rouen
• Contact: Edouard ROUSSEL, MD
• Phone: +3323288
• Email: edouard.roussel[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Recurrence

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in tcNA dosage between baseline and 6 Months	evolution of tcDNA percentage between Baseline and at 6 months after surgery	6 months
Primary	Change in tcDNA dosage between baseline and 3 Months	evolution of tcDNA percentage between Baseline and at 3 months after surgery	3 months
Secondary	Survival at 2 years	percentage of Survival 2 years after surgery	2 years