Giant Cell Tumor of the Bone in Young Patients

Sponsor
Istituto Ortopedico Rizzoli (Other)
Overall Status
Completed
CT.gov ID
NCT04002817
Collaborator
(none)
18
1
12.8
1.4

Study Details

Study Description

Brief Summary

single institution cases series review of histological and clinical data of young patient with Giant Cell Tumors

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    18 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Giant Cell Tumor of the Bone in Patients Under 15 Years Old: a Single Institution Case-series
    Actual Study Start Date :
    Jun 5, 2019
    Actual Primary Completion Date :
    Dec 30, 2019
    Actual Study Completion Date :
    Jun 30, 2020

    Outcome Measures

    Primary Outcome Measures

    1. selection and review of 50 cases of young patients with Giant Cell Tumor of bone. [at baseline (Day0)]

      Investigators will review all the medical records, radiological imaging, and histological slides of all cases in order to collect the largest pediatric series.

    Secondary Outcome Measures

    1. analysis of H3F3A mutation expression on tissue tumor material [at baseline (Day0)]

      In all cases with enough available material, immunohistochemistry will be performed on tumor tissue material. Histone 3.3 (H3.3) genes, and H3F3A mutation will be analyzed with immunohistochemistry and/or by allele specific-PCR analysis in order to confirm that the lesions are a giant cell tumors of bone occurring in a non-canonic age group (skeletally immature patients).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Male and female patients under 15 years old treated at Rizzoli Institute from 01 January 1982 to 31 December 2018.

    2. Diagnosis of giant cell tumor of bone, aneurysmatic bone cysts with solid features and giant cell reparative granuloma.

    3. Histological slides/formalin-fixed paraffin-embedded tissue tumor blocks from archive available to perform the histology analysis

    4. Written informed consent prior to any study-specific analysis and/or data collection

    Exclusion Criteria:
    1. Patients with histological diagnosis different from diagnosis of giant cell tumor, aneurysmatic bone cysts with solid features, and giant cell reparative granuloma.

    2. Patients with no available material for additional immunohistochemical and molecular analysis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istituto Ortopedico Rizzoli Bologna Italy 40136

    Sponsors and Collaborators

    • Istituto Ortopedico Rizzoli

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Istituto Ortopedico Rizzoli
    ClinicalTrials.gov Identifier:
    NCT04002817
    Other Study ID Numbers:
    • Pediatric GCTB
    First Posted:
    Jul 1, 2019
    Last Update Posted:
    May 4, 2021
    Last Verified:
    Jun 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 4, 2021