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.
Fondazione IRCCS Policlinico San Matteo di Pavia
53 participants
Jun 19, 2023
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria11
- 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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06899854