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

NCT04800497 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2024-01-17

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Hepatic resection

Hepatic resection for HCC

Sponsors & Collaborators

  • Università degli Studi del Piemonte Orientale Amedeo Avogadro

    collaborator OTHER

  • Niguarda Hospital

    collaborator OTHER

  • Humanitas Clinical and Research Center

    collaborator OTHER

  • Azienda Ospedaliero Universitaria Maggiore della Carita

    collaborator OTHER

  • University of Milano Bicocca

    lead OTHER

Principal Investigators

  • Fabrizio Romano · University of Milano Bicocca

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-07
Primary Completion
2026-02-07
Completion
2026-02-07

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04800497 on ClinicalTrials.gov