New tool to select liver transplant candidates for liver cancer
Evaluation of the HepatoPredict Prognostic Tool in the Decision of Liver Transplant in Hepatocellular Carcinoma
This study is testing a new tool to see if it can help doctors choose more patients with liver cancer for liver transplants, even if they don't meet the usual criteria.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Centro Hospitalar de Lisboa Central Academic / other |
| Locations | 1 site (Lisbon) |
| Trial ID | NCT04499833 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the selection of patients with hepatocellular carcinoma (HCC) for liver transplant by using the HepatoPredict Prognostic Tool. This tool combines clinical and molecular criteria to better predict tumor behavior and aggressiveness, potentially allowing patients who do not meet the traditional Milan Criteria to be considered for transplantation. Patients aged 18 to 70 with specific tumor characteristics will undergo genomic analysis to determine their eligibility for liver transplant. The study will follow these patients for up to 60 months post-transplant to assess survival and recurrence of HCC.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with hepatocellular carcinoma in cirrhosis who do not meet the Milan Criteria but have specific tumor characteristics.
Not a fit: Patients who are eligible under the Milan Criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could expand the pool of candidates eligible for liver transplant, improving outcomes for patients with HCC.
How similar studies have performed: While the use of molecular markers in transplant eligibility is an emerging field, this specific approach with the HepatoPredict tool is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Hepatocellular carcinoma associated with cirrhosis * Ages between 18 and 70 years * Total tumour volume below 500 cm3 * Total number of tumour lesions below 10 * Maximum individual tumour diameter below 10 cm Exclusion Criteria: * eligible under the "Milan Criteria"
Where this trial is running
Lisbon
- Centro Hepato-bilio-pancreático e de Transplantação do Hospital Curry Cabral — Lisbon, Portugal (Recruiting)
Study contacts
- Principal investigator: Hugo Pinto-Marques, MD PhD — Centro Hospitalar Universitário de Lisboa Central
- Study coordinator: Hugo Pinto-Marques, MD PhD
- Email: hugo.marques3@chlc.min-saude.pt
- Phone: +351917302214
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.