NCT06899854

Collection of Blood and Tissue Samples From Patients With Primary Liver Cancer.

Collection of Blood and Tissue Samples From Patients With Primary Liver Cancer Undergoing Systemic Therapy, Surgical Resection, or Liver Biopsy.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 53 (estimated)
• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The project aims to collect blood, tissue samples, and clinical data from patients with primary liver cancer (mainly hepatocellular carcinoma and intrahepatic cholangiocarcinoma) undergoing systemic therapy, surgical resection, or liver biopsy. Primary liver cancer is a growing global health challenge, with over one million cases expected by 2025 and a lack of effective treatments. The three-year study will systematically collect and store samples to support translational research for new therapies. Blood will be drawn at key points during systemic therapy, while tissue samples will be obtained from surgical resections or biopsies, provided they are not needed for diagnostics.

Detailed description

The project aims to collect blood and tissue samples, as well as clinical data, from patients with primary liver cancer undergoing systemic therapy, surgical resection, or liver biopsy. Primary liver cancers represent a global health challenge, with an estimated incidence exceeding one million cases by 2025. Hepatocellular carcinoma (HCC) is the most common form, accounting for approximately 90% of cases. The second most common type, intrahepatic cholangiocarcinoma (iCCA), is an epithelial tumor arising along second-order bile ducts, often in patients without known risk factors. The lack of effective therapies, along with the increasing incidence and mortality rates, drives the need to explore new therapeutic approaches. These approaches require robust translational studies, which can only be conducted through the systematic collection of biological samples from patients undergoing systemic therapy. The three-year study plans to collect, process, and store blood and tissue samples from patients with primary liver cancer undergoing systemic therapy, surgical resection, or liver biopsy. For each patient undergoing systemic therapy, blood will be drawn at the start of therapy, during clinical follow-ups (first three), at the end of therapy, and at the first post-therapy imaging assessment. From patients undergoing surgical resection, in addition to blood, a tissue sample not required for diagnostic purposes will be obtained. If a patient undergoes a liver biopsy and consents to participate in the study, a blood sample will be collected, and a biopsy tissue sample not needed for diagnostic purposes will be obtained.

Conditions

• Hepatocellular Carcinoma (HCC)
• Cholangiocarcinoma

Timeline

• Start date: 2023-06-19
• Primary completion: 2025-03-19
• Completion: 2026-03-01
• First posted: 2025-03-28
• Last updated: 2025-04-03

Locations

1 site across 1 country: Italy