Giant Cell Tumor of the Bone in Young Patients

Giant Cell Tumor of Bone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04002817
• Other study ID #: Pediatric GCTB
• Status: Completed
• Start date: June 5, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: June 2019
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Neoplasms
• Giant Cell Tumor of Bone
• Giant Cell Tumors

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Al-Ibraheemi A, Inwards CY, Zreik RT, Wenger DE, Jenkins SM, Carter JM, Boland JM, Rose PS, Jin L, Oliveira AM, Fritchie KJ. Histologic Spectrum of Giant Cell Tumor (GCT) of Bone in Patients 18 Years of Age and Below: A Study of 63 Patients. Am J Surg Pat — View Citation

Campanacci M, Baldini N, Boriani S, Sudanese A. Giant-cell tumor of bone. J Bone Joint Surg Am. 1987 Jan;69(1):106-14. — View Citation

Dahlin DC, Cupps RE, Johnson EW Jr. Giant-cell tumor: a study of 195 cases. Cancer. 1970 May;25(5):1061-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	selection and review of 50 cases of young patients with Giant Cell Tumor of bone.	Investigators will review all the medical records, radiological imaging, and histological slides of all cases in order to collect the largest pediatric series.	at baseline (Day0)
Secondary	analysis of H3F3A mutation expression on tissue tumor material	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).	at baseline (Day0)