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Completed

NCT Number: NCT04002817

Giant Cell Tumor of the Bone in Young Patients

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

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Key information

Conditions

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

Age range

Up to 15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female patients under 15 years old treated at Rizzoli Institute from 01 January 1982 to 31 December 2018.
  • Diagnosis of giant cell tumor of bone, aneurysmatic bone cysts with solid features and giant cell reparative granuloma.
  • Histological slides/formalin-fixed paraffin-embedded tissue tumor blocks from archive available to perform the histology analysis
  • Written informed consent prior to any study-specific analysis and/or data collection

Exclusion criteria

  • Patients with histological diagnosis different from diagnosis of giant cell tumor, aneurysmatic bone cysts with solid features, and giant cell reparative granuloma.
  • Patients with no available material for additional immunohistochemical and molecular analysis

Treatment and study plan

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jul 1, 2019
Registry last updated
May 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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