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NCT06894524Not yet recruiting

Retrospective Clinical Validation of HepatoPredict

Retrospective Clinical Validation of HepatoPredict, a Prognostic Tool for Hepatic Surgery Based on a Molecular Signature

Source: ClinicalTrials.gov · Last updated 25 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

HepatoPredict is an innovative prognostic tool to support hepatologists, hepatobiliary surgeons and multidisciplinary teams in deciding on the best therapeutical approach for a patient with Hepatocellular Carcinoma, the most common type of primary liver cancer. HepatoPredict is a laboratory test that analyses a molecular signature from a small tumour sample and combines this information with details from imaging tests, such as the number of nodules and their size. Using a computational model, HepatoPredict determines whether a patient is likely to remain disease-free after hepatic surgery (good prognosis) or if there is a higher chance of the tumour returning (bad prognosis). Current selection criteria to assess the eligibility of patients with Hepatocellular Carcinoma for liver transplantation present several problems, including: 1. selection of patients that will not benefit from a transplant. This could be due to recurrence of cancer or early death from another cause. 2. exclusion of patients who could benefit from a liver transplant but are currently not eligible; 3. increased tumor recurrence rates. Thus, improved tools that predict the likelihood of cancer coming back are needed to better assess if a patient will benefit from hepatic surgery. This will allow better use of organs, waiting list times, and improve ways of identifying the most appropriate treatments for individual patients. HepatoPredict accurately selects patients for hepatic surgery, outperforming conventional clinical criteria. In previous retrospective studies, HepatoPredict predicted successful surgery outcomes in patients who were not eligible by currently used criteria. This study aims to retrospectively validate the prognostic tool HepatoPredict in assessing how well a patient with Hepatocellular Carcinoma performed considering recurrence-free survival (no cancer recurrence) and overall survival after 5 years follow-up after liver surgery or liver transplantation.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
200 (estimated)
First submitted
18 Mar 2025
Start date
Mar 2025
Primary completion date
30 Apr 2026
Lead sponsor
Ophiomics
NCT number
NCT06894524

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From Mar 2025 to the primary completion date, 30 Apr 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Other non-HCC liver cancers patients.

Age

  • Age \< 18 years old.

Other

  • Patients with tumor extra-hepatic spread at diagnosis.

Who the study is looking for

  • Age ≥ 18 years old.
  • Patients with HCC that underwent transplantation, with at least 5 years follow-up.
  • Patients with HCC that underwent surgical resection, with at least 5 years follow-up.
  • Completed informed consent process (for patient candidates that are still alive).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.