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

NCT04800497 | Recruiting

• 1 other identifier: FINDINGBIOREC
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 4

Brief 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

Hepatocellular Carcinoma; Recurrent Hepatocellular Carcinoma; Circulating Tumor Cell

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Association between circulating tumor cells and overall survival

  5 years

Study Arms (2)

Patients resected for hepatocellular carcinoma

Surgical resection, peripheral blood sampling

Procedure: Hepatic resection

Patients who underwent surgery for benign diseases

Surgical resection, peripheral blood sampling

Interventions

Hepatic resection PROCEDURE

Hepatic resection for HCC

Patients resected for hepatocellular carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Planned number of subjects to be screened for resection group: almost 40 per year (patients treated/year in centres already registered as participating). Final number of enrolled at the end of the period: 80 patients. Planned number of subjects to be screened for OLT group: almost 30 per year. Final number of enrolled at the end of the period: 60 patients.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milano Bicocca: lead
• Università degli Studi del Piemonte Orientale Amedeo Avogadro: collaborator
• Niguarda Hospital: collaborator
• Humanitas Clinical and Research Center: collaborator
• Azienda Ospedaliero Universitaria Maggiore della Carita: collaborator

Study Sites (4)

Ospedale San Gerardo

Monza, MB, 20900, Italy

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

RECRUITING

Università del Piemonte Orientale

Novara, Italy

RECRUITING

Humanitas Research Hospital

Rozzano, Italy

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood mononucleate cells (PBMC) and liver tissue samples from tumor and peritumoral parenchyma

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fabrizio Romano

  University of Milano Bicocca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone Famularo

CONTACT

+39 3296533353; simone.famularo@gmail.com

Cristina Ciulli

CONTACT

+39 3896460025; cri.ciulli@hotmail.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Fabrizio Romano

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 16, 2021
• Study Start: February 7, 2019
• Primary Completion: February 7, 2026
• Study Completion: February 7, 2026
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

IT (4)