NCT04002817

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2019

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

May 4, 2021

Status Verified

June 1, 2019

Enrollment Period

7 months

First QC Date

June 25, 2019

Last Update Submit

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

AgeUp to 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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.

  • 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 Pathol. 2016 Dec;40(12):1702-1712. doi: 10.1097/PAS.0000000000000715.

  • Dahlin 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.

MeSH Terms

Conditions

Giant Cell Tumor of Bone

Condition Hierarchy (Ancestors)

Giant Cell TumorsNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Bone Tissue

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

Locations