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

NCT06899854 | Recruiting

• 1 other identifier: p_129_2023
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma (HCC); Cholangiocarcinoma

Keywords

immunotherapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants with HCC or CCA as assessed by extraction of PBMC and infiltrating cells

  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.

  From enrollment to the end of treatment at 6 months

Study Arms (2)

Patients with HCC

Patients with a diagnosis of HCC

Patients with CCA

Patients with a diagnosis of CCA

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis of HCC or CCA eligible to start first-line systemic therapy

You may qualify if:

• Primary liver cancer (hepatocellular carcinoma or intrahepatic cholangiocarcinoma)
• Signed informed consent
• Patient eligible to start first-line systemic therapy
• Patient eligible for surgical resection

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Pavia, 27100, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Cholangiocarcinoma

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

Central Study Contacts

Mario Mondelli, MD

CONTACT

0382501808; mario.mondelli@unipv.it

Stefania Mantovani, MSc

CONTACT

s.mantovani@smatteo.pv.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 28, 2025
• Study Start: June 19, 2023
• Primary Completion: March 19, 2025
• Study Completion: March 1, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

IT (1)