Clinical trial · Observational
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Patients with HCC
- description
- Patients with a diagnosis of HCC
- label
- Patients with CCA
- description
- Patients with a diagnosis of CCA
Primary outcomes (1)
- measure
- Number of Participants with HCC or CCA as assessed by extraction of PBMC and infiltrating cells
- timeFrame
- From enrollment to the end of treatment at 6 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available