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

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ClinicalTrials.gov Identifier: NCT05556642
Recruitment Status : Recruiting
First Posted : September 27, 2022
Last Update Posted : October 3, 2022
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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

Condition or disease Intervention/treatment
Relapsed Hepatoblastoma Refractory Hepatoblastoma Other: Biospecimen collection

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
Official Title: Relapsed and Refractory Hepatoblastoma: A Prospective Registry and Hepatic Tumors Research Consortium Initiative
Actual Study Start Date : September 7, 2022
Estimated Primary Completion Date : September 1, 2032
Estimated Study Completion Date : September 1, 2040

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1
Patients with relapsed/ refractory Hepatoblastoma
Other: Biospecimen collection
Clinical information and biospecimens will be collected




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with relapsed or refractory Hepatoblastoma
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05556642


Contacts
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Contact: rrHBL Registry 844-722-8774 ext Option 1 rrHBLRegistry@cchmc.org

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Study Chair: James Geller, MD Children's Hospital Medical Center, Cincinnati
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT05556642    
Other Study ID Numbers: rrHBL Registry
First Posted: September 27, 2022    Key Record Dates
Last Update Posted: October 3, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatoblastoma
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms