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

NCT05556642 | Recruiting

• 1 other identifier: rrHBL Registry
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Conditions

Relapsed Hepatoblastoma; Refractory Hepatoblastoma

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  From enrollment until data analysis is complete - assessed up to 40 years

Study Arms (1)

Group 1

Patients with relapsed/ refractory Hepatoblastoma

Other: Biospecimen collection

Interventions

Biospecimen collection OTHER

Clinical information and biospecimens will be collected

Group 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with relapsed or refractory Hepatoblastoma

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Related Links

• Relapsed and Refractory Hepatoblastoma (rrHBL) Registry website
• Relapsed and Refractory Hepatoblastoma (rrHBL) Registry website

Biospecimen

Retention: SAMPLES WITH DNA

The following biospecimens will be collected: 1. Fresh/ Frozen/ FFPE Tissue (DNA and RNA extraction may occur) 2. Optional biospecimens include: 1. urine (stored) 2. blood (DNA and RNA extraction may occur) 3. saliva (stored and DNA extraction may occur) 4. tissue for tumor modeling, drug testing, or other applicable cancer-related research.

MeSH Terms

Conditions

Hepatoblastoma

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Katherine Somers, MD

  Children's Hospital Medical Center, Cincinnati

  STUDY CHAIR

Central Study Contacts

rrHBL Registry

CONTACT

844-722-8774; rrHBLRegistry@cchmc.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 27, 2022
• Study Start: September 7, 2022
• Primary Completion (Estimated): September 1, 2032
• Study Completion (Estimated): September 1, 2040
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

US (1)