Giant Cell Tumor of the Bone in Young Patients

Completed

• Conditions: Giant Cell Tumor of Bone

• Registration Number: NCT04002817
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-06
• Study Start: 2019-06-05
• Study First Submitted: 2019-06-25
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-07-01
• Primary Completion: 2019-12-30
• Study Completion: 2020-06-30
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy