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Cohort study to assess the impact of ctDNA detection in the follow-up and management of patients with hepatocellular carcinoma treated by TACE
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNA | Biological | ctDNA; cfDNA |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 4 to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival and overall survival | progression-free Survival and overall Survival (months) | 4 to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincent VERDIER, MD | Contact | +33 2 32 88 86 10 | vincent.verdier@chu-rouen.fr |
| Name | Affiliation | Role |
|---|---|---|
| Vincent VERDIER, MD | vincent.verdier@chu-rouen.fr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Rouen | Recruiting | Rouen | 76031 | France |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D004247 | DNA |
| ID | Term |
|---|---|
| D009696 | Nucleic Acids |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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cfDNA ; ctDNA
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |