Circulating Tumor DNAMona-LisaNCT05390112
Cohort Study of Patients With Hepatocellular Carcinoma and Circulating Tumor DNA Monitoring of Chemoembolization
An observational study of Circulating Tumor DNA and Hepatocellular Carcinoma Non-resectable, run by University Hospital, Rouen at 1 site in France.
Trial summary
Cohort study to assess the impact of ctDNA detection in the follow-up and management of patients with hepatocellular carcinoma treated by TACE Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Circulating Tumor DNA, Hepatocellular Carcinoma Non-resectable, Transarterial Chemoembolization
- What is being tested?
- DNA
- How many people
- 167 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: * Patient with a first TACE (naive) or not, regardless of the number of previous procedures * Patient naïve or on a new line of oncological treatment, regardless of the number of previous lines of treatment.
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 with non-tumor liver parenchyma) at the portal phase or late phase compared with non-tumor parenchyma.
- Histologically diagnosed HCC in the absence of an imaging diagnosis
- Patient with a first TACE (naive) or not, regardless of the number of previous procedures
- Patient naïve or on a new line of oncological treatment, regardless of the number of previous lines of treatment.
- Treatment decision validated by the digestive oncology staff.
- Patient having read and understood the information letter and signed the informed consent.
- Patient follow-up performed at the Charles Nicolle University Hospital in Rouen.
Who cannot join
- Other active cancer or hematological malignancy, currently being treated
- Patient not affiliated to the social security system
- Pregnant woman or woman in labour or breastfeeding
- Person deprived of liberty by an administrative or judicial decision
- Person placed under court protection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Rouen
Rouen, 76031
Vincent Verdier, MD, +33 2 32 88 86 10, vincent.verdier@chu-rouen.fr
About this study
Cohort study to assess the impact of ctDNA detection in the follow-up and management of patients with hepatocellular carcinoma treated by TACE
Read the detailed description
The incidence of hepatocellular carcinoma (HCC) has increased significantly over the past 30 years.
The majority of HCCs present at an intermediate stage, ineligible for a curative surgical approach and the reference treatment in this situation corresponds to a palliative locoregional treatment of Transarterial chemoembolization (TACE). This treatment modality can be repeated several times and the interval between each session as well as the modalities to evaluate the efficacy of this procedure remain poorly codified. This evaluation is currently based on imaging performed at one month (M1) (MRI and/or CT scan) more or less associated with the study of the variation of the alphafetoprotein level measured before (baseline) and after (M1) the treatment. However, these evaluation tools have many limitations and remain imperfect in predicting response to treatment.
In this context, liquid biopsy, which is experiencing significant growth in oncology, could be a promising tool. It is characterized by the detection of tumor elements in the bloodstream such as circulating tumor DNA (ctDNA). Several studies have successfully demonstrated the diagnostic or prognostic value of ctDNA in patients followed for HCC.
the aim of our study is to evaluate the impact of ctDNA detection in the follow-up of patients treated by TACE.
- Conditions
- Circulating Tumor DNA, Hepatocellular Carcinoma Non-resectable, Transarterial Chemoembolization
- Being tested
- DNA
- Keywords
- cell-free DNA; circulating tumor DNA; hepatocellular carcinoma;
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNABiological
ctDNA; cfDNA
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological response at 1 month according to mRECIST and ctDNA detection
radiological response : mRECIST (progressive disease; stable disease, partial response, complete response) LIRADS (LR-TR Nonviable, LR-TR Equivocal, LR-TR Viable); ctDNA at 1 month detection (yes or no)
Measured: 4 to 6 weeks
Secondary outcomes (1)
Progression-free survival and overall survival
progression-free Survival and overall Survival (months)
Measured: 4 to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start20 May 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulating Tumor DNAStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 167 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent VERDIER, MD, Principal investigator, vincent.verdier@chu-rouen.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390112
- Sponsor's protocol ID
- 2019/330/OB
- Acronym
- Mona-Lisa
- Status last verified
- May 2022
- First submitted
- 9 May 2022
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Patients With Hepatocellular Carcinoma and Circulating Tumor DNA Monitoring of Chemoembolization
- ClinicalTrials.gov ID
- NCT05390112
- Acronym / sponsor ID
- Mona-Lisa / 2019/330/OB
- Conditions
- Circulating Tumor DNA, Hepatocellular Carcinoma Non-resectable, Transarterial Chemoembolization
- Keywords
- cell-free DNA; circulating tumor DNA; hepatocellular carcinoma;
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 167 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 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.
Cohort study to assess the impact of ctDNA detection in the follow-up and management of patients with hepatocellular carcinoma treated by TACE
Detailed description
The incidence of hepatocellular carcinoma (HCC) has increased significantly over the past 30 years.
The majority of HCCs present at an intermediate stage, ineligible for a curative surgical approach and the reference treatment in this situation corresponds to a palliative locoregional treatment of Transarterial chemoembolization (TACE). This treatment modality can be repeated several times and the interval between each session as well as the modalities to evaluate the efficacy of this procedure remain poorly codified. This evaluation is currently based on imaging performed at one month (M1) (MRI and/or CT scan) more or less associated with the study of the variation of the alphafetoprotein level measured before (baseline) and after (M1) the treatment. However, these evaluation tools have many limitations and remain imperfect in predicting response to treatment.
In this context, liquid biopsy, which is experiencing significant growth in oncology, could be a promising tool. It is characterized by the detection of tumor elements in the bloodstream such as circulating tumor DNA (ctDNA). Several studies have successfully demonstrated the diagnostic or prognostic value of ctDNA in patients followed for HCC.
the aim of our study is to evaluate the impact of ctDNA detection in the follow-up of patients treated by TACE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Patient with a first TACE (naive) or not, regardless of the number of previous procedures * Patient naïve or on a new line of oncological treatment, regardless of the number of previous lines of treatment.
Key inclusion criteria (8 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 with non-tumor liver parenchyma) at the portal phase or late phase compared with non-tumor parenchyma.
- Histologically diagnosed HCC in the absence of an imaging diagnosis
- Patient with a first TACE (naive) or not, regardless of the number of previous procedures
- Patient naïve or on a new line of oncological treatment, regardless of the number of previous lines of treatment.
Key exclusion criteria (5 listed)
- Other active cancer or hematological malignancy, currently being treated
- Patient not affiliated to the social security system
- Pregnant woman or woman in labour or breastfeeding
- Person deprived of liberty by an administrative or judicial decision
- Person placed under court protection
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 |
|---|---|---|
| DNActDNA; cfDNA | Biological | – |
Primary outcome
Radiological response at 1 month according to mRECIST and ctDNA detection
Time frame: 4 to 6 weeks
radiological response : mRECIST (progressive disease; stable disease, partial response, complete response) LIRADS (LR-TR Nonviable, LR-TR Equivocal, LR-TR Viable); ctDNA at 1 month detection (yes or no)
1 secondary outcome
Progression-free survival and overall survival
Time frame: 4 to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- 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. This study is not recruiting at the moment.
Vincent VERDIER, MD principal investigator
vincent.verdier@chu-rouen.fr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circulating Tumor DNA and Hepatocellular Carcinoma Non-resectable, 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 8 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: status not confirmed, as of the sponsor's last update on 25 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent VERDIER, MD (+33 2 32 88 86 10, vincent.verdier@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological response at 1 month according to mRECIST and ctDNA detection (time frame: 4 to 6 weeks). 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 25 May 2022.