Registry for Relapsed or Refractory Hepatoblastoma

This study is an observational registry for patients with relapsed or refractory hepatoblastoma (rrHBL), a type of liver cancer that has returned or not responded to treatment. The goal is to gather information and biological samples (like tissue) from patients to better understand rrHBL. Researchers will collect clinical details, imaging, and tissue samples to learn more about this condition and how it responds to different treatments. This information will help create a resource for future research. Anyone with a suspected or confirmed diagnosis of rrHBL, or a similar liver cancer called Hepatocellular Malignant Neoplasm-Not Otherwise Specified (HCN-NOS) who is under 6 years old at initial diagnosis, can potentially join. The study aims to characterize rrHBL and create a biorepository of specimens, with data correlation over many years.

Study design
This is an observational study that plans to enroll up to 500 participants. It is not testing a specific drug or treatment.
What's involved
You would allow researchers to collect your clinical information, imaging, and biological samples (like tissue) from your diagnosis and any future procedures. This information will be used for research.
Compensation
Not stated in the trial record.
Follow-up
Your information will be collected from enrollment until data analysis is complete, which could be up to 40 years.

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NCT05556642

Relapsed and Refractory Hepatoblastoma: A Prospective Registry and Liver Tumor Research Consortium Initiative

Recruiting
Not specifiedAll AgesObservational
Children's Hospital Medical Center, Cincinnati
~500 participants
Updated 2026-03-18 on ClinicalTrials.gov
What's tested:Biospecimen collection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Characterization of relapsed or refractory Hepatoblastoma
Measured over From enrollment until data analysis is complete - assessed up to 40 years
+2 more outcomes measured
Relapsed Hepatoblastoma
Refractory Hepatoblastoma
1 sites across 1 states
Ohio1
  • Katherine Somers, MD · STUDY_CHAIR · Children's Hospital Medical Center, Cincinnati

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Eligibility criteria

Inclusion

All patients of any age with a suspected diagnosis (per treating oncologist/surgeon) or confirmed diagnosis of a rrHBL and all patients with Hepatocellular Malignant Neoplasm- Not Otherwise Specified (HCN-NOS) who are \<6 years of age at the time of initial diagnosis
To allow for tumor modelling to be performed with fresh tissue from these cases, patients with suspected rrHBL are eligible to enroll on study
Unless the patient is deceased, all patients and/or one parent or legal guardian must provide written informed consent as well as HIPAA/release of information consent

Exclusion

None
  • Characterization of relapsed or refractory HepatoblastomaFrom enrollment until data analysis is complete - assessed up to 40 years

    To characterize rrHBL across all age groups with regards to demographics, presenting features, pathology, radiology, clinical course, treatments and response

  • Create biorepository of specimensFrom enrollment until data analysis is complete - retained up to 40 years

    To create a biorepository of specimens from patients with rrHBL or suspected to have rrHBL to enhance molecular/biological investigations

  • Clinical data and biological data correlationFrom enrollment until data analysis is complete - assessed up to 40 years

    To correlate registry clinical data with biological/bioinformatic data