Recruiting

Observational Study

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT05556642

Conditions

Relapsed Hepatoblastoma

Refractory Hepatoblastoma

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Biospecimen collection

Study Details

Brief summary:

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:

1. Existing clinical and/or cancer registry databases
2. Referrals from clinicians, surgeons, or pathologists
3. Families initiating contact with Registry staff directly

Conditions

Relapsed Hepatoblastoma

Refractory Hepatoblastoma

Study ID

NCT05556642

Start date

Sep 7, 2022

Status verified date

Mar, 2026

Completion date

Sep 1, 2040

Anticipated

Primary completion date

Sep 1, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • None

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1

Patients with relapsed/ refractory Hepatoblastoma

Interventions

Biospecimen collection

Clinical information and biospecimens will be collected

Primary outcome measure

  • Characterization of relapsed or refractory Hepatoblastoma [ Time Frame: From enrollment until data analysis is complete - assessed up to 40 years ]
  • Create biorepository of specimens [ Time Frame: From enrollment until data analysis is complete - retained up to 40 years ]
  • Clinical data and biological data correlation [ Time Frame: From enrollment until data analysis is complete - assessed up to 40 years ]

Central Contacts and Locations

Central contacts

rrHBL Registry

844-722-8774rrHBLRegistry@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-03-18.