Collecting 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 · NCT06899854
This study is collecting blood and tissue samples from patients with primary liver cancer to help researchers find new treatments for the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 53 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia (other) |
| Locations | 1 site (Pavia, Pavia) |
| Trial ID | NCT06899854 on ClinicalTrials.gov |
What this trial studies
This project aims to collect blood and tissue samples, along with clinical data, from patients diagnosed with primary liver cancer, specifically hepatocellular carcinoma and intrahepatic cholangiocarcinoma. Patients undergoing systemic therapy, surgical resection, or liver biopsy will be involved in the study, which will systematically gather and store samples over three years. Blood samples will be drawn at various points during therapy, while tissue samples will be obtained from surgeries or biopsies when not needed for diagnostics. The goal is to support translational research for developing new therapies for this growing health challenge.
Who should consider this trial
Good fit: Ideal candidates include patients with primary liver cancer who are eligible for first-line systemic therapy or surgical resection.
Not a fit: Patients with concurrent conditions that significantly limit life expectancy or those with active extrahepatic malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of new and effective therapies for primary liver cancer.
How similar studies have performed: Other studies have shown success in using similar approaches to collect biological samples for translational research in cancer treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pavia, Pavia
- Fondazione IRCCS Policlinico San Matteo di Pavia — Pavia, Pavia, Italy (RECRUITING)
Study contacts
- Study coordinator: Mario Mondelli, MD
- Email: mario.mondelli@unipv.it
- Phone: 0382501808
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hepatocellular Carcinoma, Cholangiocarcinoma, immunotherapy