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Giant Cell Tumor of the Bone in Young Patients

Giant Cell Tumor of the Bone in Patients Under 15 Years Old: a Single Institution Case-series

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04002817
Enrollment
18
Registered
2019-07-01
Start date
2019-06-05
Completion date
2020-06-30
Last updated
2021-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Giant Cell Tumor of Bone

Brief summary

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

Interventions

None listed

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 15 Years
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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
analysis of H3F3A mutation expression on tissue tumor materialat 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).

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026