Clinical trial NCT05375370: Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Monitoring Circulating Tumor DNA
Official title: Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Monitoring Circulating Tumor DNA: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: ctDNA
biomarker
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Change in tcNA dosage between baseline and 6 Months
timeFrame: 6 months
measure: Change in tcDNA dosage between baseline and 3 Months
timeFrame: 3 months
Secondary outcomes:
measure: Survival at 2 years
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Rouen
name: Edouard ROUSSEL, MD
role: PRINCIPAL_INVESTIGATOR
References: