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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mario Mondelli, MD
- Phone Number: 0382501808
- Email: mario.mondelli@unipv.it
Study Contact Backup
- Name: Stefania Mantovani, MSc
- Email: s.mantovani@smatteo.pv.it
Study Locations
-
-
-
Pavia, Italy, 27100
- Recruiting
- Fondazione IRCCS Policlinico San Matteo di Pavia
-
Contact:
- Mario Mondelli, MD
- Email: m.mondelli@smatteo.pv.it
-
Contact:
- Stefania Mantovani, Biologist
- Email: s.mantovani@smatteo.pv.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Patients with HCC
Patients with a diagnosis of HCC
|
|
Patients with CCA
Patients with a diagnosis of CCA
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants with HCC or CCA as assessed by extraction of PBMC and infiltrating cells
Time Frame: 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.
|
From enrollment to the end of treatment at 6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- p_129_2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.