Relapsed HepatoblastomaNCT05556642
Relapsed and Refractory Hepatoblastoma: A Prospective Registry and Liver Tumor Research Consortium Initiative
An observational study of Relapsed Hepatoblastoma and Refractory Hepatoblastoma, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Relapsed Hepatoblastoma, Refractory Hepatoblastoma
- What is being tested?
- Biospecimen collection
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2022to 1 Sep 2040
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with relapsed or refractory Hepatoblastoma
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Relapsed and Refractory Hepatoblastoma: A Prospective Registry and Hepatic Tumors Research Consortium Initiative
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:
- Existing clinical and/or cancer registry databases
- Referrals from clinicians, surgeons, or pathologists
- Families initiating contact with Registry staff directly
Read the detailed description
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.
- Tumor Modeling, Drug Testing, or Other Applicable Cancer-Related Research (Fresh, frozen,): Prospectively collected or retained left-over tumor tissue samples and normal tissue (background liver) as available, for research purposes.
- Blood: prospectively collected at time of enrollment and at time of subsequent relapse
- Urine: prospectively collected at time of enrollment and at time of subsequent relapse
- Saliva: prospectively collected at time of enrollment or at one time point after enrollment
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.
- Conditions
- Relapsed Hepatoblastoma, Refractory Hepatoblastoma
- Being tested
- Biospecimen collection
- Medical subject headings
- Hepatoblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen collectionOther
Clinical information and biospecimens will be collected
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with relapsed/ refractory Hepatoblastoma Receives: Other: Biospecimen collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: From enrollment until data analysis is complete - assessed up to 40 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start7 Sep 2022
- Primary completion1 Sep 2032 (estimated)
- Study completion1 Sep 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed HepatoblastomaStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Somers, MD, Study chair, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556642
- Sponsor's protocol ID
- rrHBL Registry
- Status last verified
- Mar 2026
- First submitted
- 20 Sep 2022
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relapsed and Refractory Hepatoblastoma: A Prospective Registry and Hepatic Tumors Research Consortium Initiative
- ClinicalTrials.gov ID
- NCT05556642
- Acronym / sponsor ID
- rrHBL Registry
- Conditions
- Relapsed Hepatoblastoma, Refractory Hepatoblastoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 1 Sep 2032 (estimated)
- Study completion
- 1 Sep 2040 (estimated)
- First posted
- 27 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Existing clinical and/or cancer registry databases
- Referrals from clinicians, surgeons, or pathologists
- Families initiating contact with Registry staff directly
Detailed description
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.
- Tumor Modeling, Drug Testing, or Other Applicable Cancer-Related Research (Fresh, frozen,): Prospectively collected or retained left-over tumor tissue samples and normal tissue (background liver) as available, for research purposes.
- Blood: prospectively collected at time of enrollment and at time of subsequent relapse
- Urine: prospectively collected at time of enrollment and at time of subsequent relapse
- Saliva: prospectively collected at time of enrollment or at one time point after enrollment
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Biospecimen collectionPatients with relapsed/ refractory Hepatoblastoma |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with relapsed or refractory Hepatoblastoma
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen collectionClinical information and biospecimens will be collected | Other | Group 1 |
Primary outcome
Characterization of relapsed or refractory Hepatoblastoma
Time frame: From 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 specimens
Time frame: From 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 correlation
Time frame: From enrollment until data analysis is complete - assessed up to 40 years
To correlate registry clinical data with biological/bioinformatic data
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Relapsed and Refractory Hepatoblastoma (rrHBL) Registry websiteLink provided by the sponsor.
- Relapsed and Refractory Hepatoblastoma (rrHBL) Registry websiteLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine Somers, MD study chair
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed Hepatoblastoma and Refractory Hepatoblastoma, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact rrHBL Registry (844-722-8774 ext. Option 1, rrHBLRegistry@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of relapsed or refractory Hepatoblastoma (time frame: From enrollment until data analysis is complete - assessed up to 40 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.