The Role Of Circulating Tumor Cells As Markers Of Advanced Disease And Prognosis In HCC

Study Overview
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Brief Summary
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Hepatocellular carcinoma (HCC) recurs in up to 60% of patients who undergo resection. Circulating tumor cells (CTC) have been advocated as promotors of the recurrence. However, their role as prognostic markers in the surgical setting is unclear. The aim of the present study has been to assess the association between CTC from peripheral blood samples and the risk of recurrence after surgery. Patients with a first diagnosis of HCC, no previous treatment for this condition, no other oncological history, and BCLC stage 0-A-B will be enrolled in 2 centers. Patients will undergo to serial liquid biopsies (i.e., a 15ml peripheral blood sample on each time point) at day 0-30-90-180-365 after surgery. After isolation of peripheral blood mononucleate cells, CTC will be detected by FACSymphony™ and subsequently the following markers will be identified: EpCAM, N-cadherin (N-cad) and CD90. Epithelial-mesenchymal transition (EMT) will be analyzed by an index estimated as the ratio between the number of EpCAM+/N-cad- and EpCAM+/N-cad+ cells (EMT Index). Patients will be divided according to the recurrence status.

Official Title
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Finding The Seeds Of Recurrence: The Role Of The Liquid Biopsy To Detect Circulating Tumor Cells As Markers Of Advanced Disease And Prognosis In HCC

Conditions
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Hepatocellular Carcinoma, Recurrent Hepatocellular Carcinoma, Circulating Tumor Cell

Intervention / Treatment
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* Procedure: Hepatic resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hepatocarcinoma diagnosis confirmed by radiology and committed to surgery (resection or OLT) with curative intent. First diagnosis and first treatment of hepatocellular carcinoma. BCLC 0 - A - B Histological confirmation of hepatocarcinoma at the histological specimen. Availability of a fresh frozen section of the tumor obtained during the surgical procedures Exclusion Criteria: Other tumors in the clinical history. Presence of autoimmune liver diseases (eg. sclerotising cholangitis, primary biliary cirrhosis etc.). Patients treated with surgery in case of not-curative intent (palliation, best supportive care, etc). Histopathological specimen of combined liver primary neoplasms (e.g. 'epatocolangiocarcinoma'). Patients previously treated for HCC with other therapies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients resected for hepatocellular carcinoma<br> | Procedure: Hepatic resection<br>* Hepatic resection for HCC<br>|
| Patients who underwent surgery for benign diseases<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between circulating tumor cells and disease-free-survival | To evaluate the association between variation in CTCs - determined in blood samples - and disease-free-survival in HCC patients after surgery. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between circulating tumor cells and overall survival | To evaluate the association between variation in CTCs - determined in blood samples - and overall survival in HCC patients after surgery. | 5 years |