Giant Cell Tumor of the Bone in Young Patients

May 3, 2021 updated by: Istituto Ortopedico Rizzoli

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

young patients with giant cell tumor of bone

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at baseline (Day0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
at baseline (Day0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2019

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

June 25, 2019

First Submitted That Met QC Criteria

June 26, 2019

First Posted (Actual)

July 1, 2019

Study Record Updates

Last Update Posted (Actual)

May 4, 2021

Last Update Submitted That Met QC Criteria

May 3, 2021

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pediatric GCTB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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