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Trial record 6 of 4318 for:    bone tumors AND NOT metastatic

Giant Cell Tumor of the Bone in Young Patients

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ClinicalTrials.gov Identifier: NCT04002817
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli

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

Condition or disease
Giant Cell Tumor of Bone

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Giant Cell Tumor of the Bone in Patients Under 15 Years Old: a Single Institution Case-series
Actual Study Start Date : June 5, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : June 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Cancer




Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
young patients with giant cell tumor of bone
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002817


Contacts
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Contact: Marco Gambarotti, MD 051.63.66 ext 652 marco.gambarotti@ior.it

Locations
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Italy
Istituto Ortopedico Rizzoli Recruiting
Bologna, Italy, 40136
Contact: Marco Gambarotti, MD    051.63.66 ext 652    marco.gambarotti@ior.it   
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
  Study Documents (Full-Text)

Documents provided by Istituto Ortopedico Rizzoli:
Study Protocol  [PDF] April 3, 2019


Publications of Results:
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Responsible Party: Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT04002817     History of Changes
Other Study ID Numbers: Pediatrifc GCTB
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Giant Cell Tumors
Bone Neoplasms
Giant Cell Tumor of Bone
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Bone Diseases
Neoplasms, Bone Tissue
Musculoskeletal Diseases