Assessing Circulating Tumor Cells in Hepatocellular Carcinoma Prognosis
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
This study is testing if measuring circulating tumor cells in the blood can help predict the risk of cancer coming back in patients with liver cancer after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Milano Bicocca Academic / other |
| Locations | 4 sites (Monza, MB and 3 other locations) |
| Trial ID | NCT04800497 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the role of circulating tumor cells (CTCs) as prognostic markers in patients with hepatocellular carcinoma (HCC) who are undergoing surgical resection. Patients diagnosed with HCC will provide peripheral blood samples at multiple time points after surgery to analyze the presence and characteristics of CTCs. The study will focus on understanding the association between CTC levels and the risk of cancer recurrence, which is a significant concern in HCC management. By utilizing liquid biopsy techniques, the study seeks to improve patient stratification and potentially guide future treatment approaches.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with a first diagnosis of hepatocellular carcinoma who are undergoing curative surgical treatment and have no prior oncological history.
Not a fit: Patients with a history of other tumors or those with autoimmune liver diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict recurrence in HCC patients, leading to more tailored and effective post-surgical management.
How similar studies have performed: While there have been retrospective studies indicating the potential of CTCs in other cancers, this specific approach in HCC is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Monza, MB and 3 other locations
- Ospedale San Gerardo — Monza, Mb, Italy (Recruiting)
- ASST Grande Ospedale Metropolitano Niguarda — Milano, Italy (Recruiting)
- Università del Piemonte Orientale — Novara, Italy (Recruiting)
- Humanitas Research Hospital — Rozzano, Italy (Not_yet_recruiting)
Study contacts
- Principal investigator: Fabrizio Romano — University of Milano Bicocca
- Study coordinator: Simone Famularo
- Email: simone.famularo@gmail.com
- Phone: +39 3296533353
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.