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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria:
Primary liver cancer (hepatocellular carcinoma or intrahepatic cholangiocarcinoma)
Signed informed consent
Patient eligible to start first-line systemic therapy
Patient eligible for surgical resection
Exclusion Criteria:
Concurrent conditions with a life expectancy of less than 12 months
Autoimmune or chronic inflammatory diseases
Substance abuse dependency
Other active extrahepatic malignancies or those treated within the last 3 years, except for the following exceptions:
Tumors resected with curative intent and with no evidence of disease recurrence for \>3 years prior to signing the informed consent, considered at low risk of recurrence
Adequately resected non-melanoma skin cancers or lentigo maligna with no evidence of metastasis
Adequately treated carcinoma in situ of the cervix with no evidence of recurrence
Prostatic intraepithelial neoplasia with no evidence of infiltrative disease
Adequately treated non-invasive papillary urothelial tumors or urothelial carcinoma in situ
HIV infection
Lack of patient cooperation or failure to sign the informed consent
Primary outcome measure(s)
Number of Participants with HCC or CCA as assessed by extraction of PBMC and infiltrating cells — From enrollment to the end of treatment at 6 months The primary objective of the study is the collection of peripheral blood samples to extract mononuclear cells and serum, as well as tissue samples to extract infiltrating cells and tumor cells. As regards the peripheral blood the extraction will be performed by Ficoll stratification. Infiltrating cells in the tissue will be isolated by enzymatic and mechanical dissociation of the tissue and centrifugation.
Trial sites (1)
Facility
City
Region
Status
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia
Pavia
Recruiting
More Fondazione IRCCS Policlinico San Matteo di Pavia trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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