Clinical trial · Observational
The Role Of Circulating Tumor Cells As Markers Of Advanced Disease And Prognosis In HCC
Finding The Seeds Of Recurrence: The Role Of The Liquid Biopsy To Detect Circulating Tumor Cells As Markers Of Advanced Disease And Prognosis In HCC
- 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)
Hepatocellular carcinoma (HCC) recurs in up to 60% of patients who undergo resection. Circulating tumor cells (CTC) have been advocated as promotors of the recurrence. However, their role as prognostic markers in the surgical setting is unclear. The aim of the present study has been to assess the association between CTC from peripheral blood samples and the risk of recurrence after surgery. Patients with a first diagnosis of HCC, no previous treatment for this condition, no other oncological history, and BCLC stage 0-A-B will be enrolled in 2 centers. Patients will undergo to serial liquid biopsies (i.e., a 15ml peripheral blood sample on each time point) at day 0-30-90-180-365 after surgery. After isolation of peripheral blood mononucleate cells, CTC will be detected by FACSymphony™ and subsequently the following markers will be identified: EpCAM, N-cadherin (N-cad) and CD90. Epithelial-mesenchymal transition (EMT) will be analyzed by an index estimated as the ratio between the number of EpCAM+/N-cad- and EpCAM+/N-cad+ cells (EMT Index). Patients will be divided according to the recurrence status.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Circulating Tumor Cell | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hepatic resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Patients resected for hepatocellular carcinoma
- description
- Surgical resection, peripheral blood sampling
- interventionNames
- Procedure: Hepatic resection
- label
- Patients who underwent surgery for benign diseases
- description
- Surgical resection, peripheral blood sampling
Primary outcomes (1)
- measure
- Association between circulating tumor cells and disease-free-survival
- timeFrame
- 5 years
- description
- To evaluate the association between variation in CTCs - determined in blood samples - and disease-free-survival in HCC patients after surgery.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Hepatocarcinoma diagnosis confirmed by radiology and committed to surgery (resection or OLT) with curative intent. * First diagnosis and first treatment of hepatocellular carcinoma. * BCLC 0 - A - B * Histological confirmation of hepatocarcinoma at the histological specimen. * Availability of a fresh frozen section of the tumor obtained during the surgical procedures Exclusion Criteria: * Other tumors in the clinical history. * Presence of autoimmune liver diseases (eg. sclerotising cholangitis, primary biliary cirrhosis etc.). * Patients treated with surgery in case of not-curative intent (palliation, best supportive care, etc). * Histopathological specimen of combined liver primary neoplasms (e.g. 'epatocolangiocarcinoma'). * Patients previously treated for HCC with other therapies
References
Publications (0)
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