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NCT Number: NCT05375370

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Rouen

Rouen, 76031, France

Location status: Recruiting

Location contact

Edouard Roussel, Dr

CONTACT

Edouard Roussel, Dr

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

circulating tumor DNA dosage

Other

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

Primary outcomes

  1. Change in tcNA dosage between baseline and 6 Months

    Time frame: 6 months

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

  2. Change in tcDNA dosage between baseline and 3 Months

    Time frame: 3 months

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

Secondary outcomes

  1. Survival at 2 years

    Time frame: 2 years

    percentage of Survival 2 years after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Edouard ROUSSEL, MD

CONTACT

[email protected]

+3323288 ext. 8610

Julie RONDEAUX

CONTACT

[email protected]

+3323288 ext. 5427

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

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

Acronym: REMNANT

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
May 16, 2022
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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