Hepatocellular CarcinomaREMNANTNCT05375370
Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Monitoring Circulating Tumor DNA
A study testing circulating tumor DNA dosage in people with Hepatocellular Carcinoma, run by University Hospital, Rouen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- circulating tumor DNA dosage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 4 Aug 2022to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Rouen
Rouen, 76031
Edouard Roussel, Dr
Edouard Roussel, Dr
About this study
Official title: Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Monitoring Circulating Tumor DNA: a Prospective Cohort Study
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.
Read the 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
- Being tested
- circulating tumor DNA dosage
- Keywords
- ctDNA, biomarker
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
circulating tumor DNA dosageOther
blood sample for circulating tumor DNA dosage will be done to patient with hepatocellular carcinoma
| Study group | Role | What they receive |
|---|---|---|
| Patient with hepatocellular carcinoma | Experimental | Circulating tumor DNA dosage will be done to patients with hepatocellular carcinoma Receives: Other: circulating tumor DNA dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tcNA dosage between baseline and 6 Months
evolution of tcDNA percentage between Baseline and at 6 months after surgery
Measured: 6 months
Change in tcDNA dosage between baseline and 3 Months
evolution of tcDNA percentage between Baseline and at 3 months after surgery
Measured: 3 months
Secondary outcomes (1)
Survival at 2 years
percentage of Survival 2 years after surgery
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start4 Aug 2022
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edouard ROUSSEL, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375370
- Sponsor's protocol ID
- 2020/0414/OB
- Acronym
- REMNANT
- Status last verified
- Feb 2026
- First submitted
- 10 May 2022
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Monitoring Circulating Tumor DNA: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05375370
- Acronym / sponsor ID
- REMNANT / 2020/0414/OB
- Conditions
- Hepatocellular Carcinoma
- Keywords
- ctDNA, biomarker
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with hepatocellular carcinoma | Experimental | Other: circulating tumor DNA dosageCirculating tumor DNA dosage will be done to patients with hepatocellular carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| circulating tumor DNA dosageblood sample for circulating tumor DNA dosage will be done to patient with hepatocellular carcinoma | Other | Patient with hepatocellular carcinoma |
Primary outcome
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
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
1 secondary outcome
Survival at 2 years
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edouard ROUSSEL, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing circulating tumor DNA dosage in people with Hepatocellular Carcinoma, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edouard ROUSSEL, MD (+3323288 ext. 8610, edouard.roussel@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tcNA dosage between baseline and 6 Months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.