NCT05556642 Relapsed and Refractory Hepatoblastoma: A Prospective Registry and Liver Tumor Research Consortium Initiative
| NCT ID | NCT05556642 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Relapsed Hepatoblastoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2022-09-07 |
| Primary Completion | 2032-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2022-09-07 with a primary completion date of 2032-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Katherine Somers, MD
STUDY CHAIR
Children's Hospital Medical Center, Cincinnati
Frequently Asked Questions
Who can join the NCT05556642 clinical trial?
This trial is open to participants of all sexes, studying Relapsed Hepatoblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05556642 currently recruiting?
Yes, NCT05556642 is actively recruiting participants. Contact the research team at rrHBLRegistry@cchmc.org for enrollment information.
Where is the NCT05556642 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT05556642 clinical trial?
NCT05556642 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Katherine Somers, MD at Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 500 participants.