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Giant Cell Tumor of the Bone in Young Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04002817
Recruitment Status : Completed
First Posted : July 1, 2019
Last Update Posted : May 4, 2021
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli

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

Condition or disease
Giant Cell Tumor of Bone

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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 : June 5, 2019
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Cancer

Primary Outcome Measures :
  1. selection and review of 50 cases of young patients with Giant Cell Tumor of bone. [ Time Frame: 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 [ Time Frame: 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
young patients with giant cell tumor of bone

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

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 identifier (NCT number): NCT04002817

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Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
  Study Documents (Full-Text)

Documents provided by Istituto Ortopedico Rizzoli:
Study Protocol  [PDF] April 3, 2019

Publications of Results:
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Responsible Party: Istituto Ortopedico Rizzoli Identifier: NCT04002817    
Other Study ID Numbers: Pediatric GCTB
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: June 2019

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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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Giant Cell Tumors
Bone Neoplasms
Giant Cell Tumor of Bone
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Neoplasms, Bone Tissue