An observational study in Relapsed Hepatoblastoma and Refractory Hepatoblastoma, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Children's Hospital Medical Center, Cincinnati · Observational
There are limited data regarding the biology and treatment of relapsed/refractory hepatoblastoma (rrHBL). This project provides the infrastructure for acquisition of biological specimens, imaging, and correlative clinical data to facilitate biology studies and characterization of rrHBL. This registry will collect clinical, demographic, and pathological data, specimens (as available) and imaging from patients with rrHBL, prospectively. Cases are identified through:
The following data/materials will be collected:
Clinical Data: Demographic data, date of diagnosis, pathology, radiological imaging data, signs and symptoms at diagnosis, molecular and biological data, staging details including sites of disease, detailed treatment data (e.g. types and dates of surgeries/interventional therapy (if any), medical/systemic therapy, radiotherapy), response to treatment (imaging and tumor markers), dates of progression, types of progression (local or metastatic), and follow-up data. The demographic and clinical data collected are abstracted and entered into an electronic data system secured by password protection. Collection of existing molecular and/or genomic data or analysis that has been performed will also be included.
Research Specimens:
Tissue (fresh/frozen/FFPE) from diagnosis and all subsequent timepoints where tissue was acquired (for example at each relapse and/or progression) will be requested for all enrolled patients and sent for central review to the study pathologist and stored in the rrHBL biorepository within the Cancer and Blood Disease Institute at Cincinnati Children's Hospital Medical Center. Future research testing may be conducted on this tissue.
Optional research specimens:
Pending consent specification of family/patient, and resources, specimens may be sent directly to collaborating laboratories to proceed with tumor modeling and drug testing, or other translational research with PI or designee via an Institutional Review Board approved project.
Registry clinical data will be correlated with biological/bioinformatic and genomic data. Data stored in the Registry may be used to provide statistical data for scientific presentations and for preparation of peer- reviewed manuscripts.
70 studies on the registry are indexed under Hepatoblastoma; 18 are open to participants now.
This study's planned enrollment of 500 is above the median of 150 across 13 observational studies indexed under Hepatoblastoma.
Browse Hepatoblastoma studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with relapsed or refractory Hepatoblastoma
Exclusion Criteria:
Patients with relapsed/ refractory Hepatoblastoma
Other: Biospecimen collection
Clinical information and biospecimens will be collected
Characterization of relapsed or refractory Hepatoblastoma
To characterize rrHBL across all age groups with regards to demographics, presenting features, pathology, radiology, clinical course, treatments and response
Time frame: From enrollment until data analysis is complete - assessed up to 40 years
Create biorepository of specimens
To create a biorepository of specimens from patients with rrHBL or suspected to have rrHBL to enhance molecular/biological investigations
Time frame: From enrollment until data analysis is complete - retained up to 40 years
Clinical data and biological data correlation
To correlate registry clinical data with biological/bioinformatic data
Time frame: From enrollment until data analysis is complete - assessed up to 40 years
Plan to share: Undecided — Studies submitted from other researchers will be approved by the Hepatic Tumors Research Consortium Steering Committee (HTRC SC) and will have appropriate Institutional Review Board approvals/determinations received by the Registry staff.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Children's Hospital Medical Center, Cincinnati