Giant Cell Tumor of the Bone in Young Patients
1 other identifier
observational
18
1 country
1
Brief Summary
single institution cases series review of histological and clinical data of young patient with Giant Cell Tumors
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 5, 2019
CompletedFirst Submitted
Initial submission to the registry
June 25, 2019
CompletedFirst Posted
Study publicly available on registry
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedMay 4, 2021
June 1, 2019
7 months
June 25, 2019
May 3, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
analysis of H3F3A mutation expression on tissue tumor material
at baseline (Day0)
Eligibility Criteria
young patients with giant cell tumor of bone
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istituto Ortopedico Rizzoli
Bologna, 40136, Italy
Related Publications (3)
Campanacci M, Baldini N, Boriani S, Sudanese A. Giant-cell tumor of bone. J Bone Joint Surg Am. 1987 Jan;69(1):106-14.
PMID: 3805057RESULTAl-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 Pathol. 2016 Dec;40(12):1702-1712. doi: 10.1097/PAS.0000000000000715.
PMID: 27526293RESULTDahlin DC, Cupps RE, Johnson EW Jr. Giant-cell tumor: a study of 195 cases. Cancer. 1970 May;25(5):1061-70. doi: 10.1002/1097-0142(197005)25:53.0.co;2-e. No abstract available.
PMID: 4910256RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2019
First Posted
July 1, 2019
Study Start
June 5, 2019
Primary Completion
December 30, 2019
Study Completion
June 30, 2020
Last Updated
May 4, 2021
Record last verified: 2019-06