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

Last updated: December 9, 2024
Sponsor: Children's Hospital Medical Center, Cincinnati
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatoblastoma

Treatment

Biospecimen collection

Clinical Study ID

NCT05556642
rrHBL Registry
  • All Genders

Study 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

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 MalignantNeoplasm- Not Otherwise Specified (HCN-NOS) who are <6 years of age at the time ofinitial 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 guardianmust provide written informed consent as well as HIPAA/release of informationconsent

Exclusion

Exclusion Criteria:

  • None

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Biospecimen collection
Phase:
Study Start date:
September 07, 2022
Estimated Completion Date:
September 01, 2040

Study 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.

Connect with a study center

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

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