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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Ospedale San Gerardo
RECRUITING
Monza
Università del Piemonte Orientale
RECRUITING
Novara
Humanitas Research Hospital
NOT_YET_RECRUITING
Rozzano
Contact Information
Primary
Simone Famularo
simone.famularo@gmail.com
+39 3296533353
Backup
Cristina Ciulli
cri.ciulli@hotmail.it
+39 3896460025
Time Frame
Start Date: 2019-02-07
Estimated Completion Date: 2026-02-07
Participants
Target number of participants: 70
Treatments
Patients resected for hepatocellular carcinoma
Surgical resection, peripheral blood sampling
Patients who underwent surgery for benign diseases
Surgical resection, peripheral blood sampling
Related Therapeutic Areas
Sponsors
Collaborators: Università degli Studi del Piemonte Orientale Amedeo Avogadro, Humanitas Clinical and Research Center, Azienda Ospedaliero Universitaria Maggiore della Carita, Niguarda Hospital
Leads: University of Milano Bicocca

This content was sourced from clinicaltrials.gov

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