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Giant Cell Tumor of the Extremities Treated With Surgery and/or Medical Treatment (GCTLIMBS)

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ClinicalTrials.gov Identifier: NCT02996734
Recruitment Status : Completed
First Posted : December 19, 2016
Last Update Posted : December 22, 2016
Sponsor:
Information provided by (Responsible Party):
Costantino Errani, Istituto Ortopedico Rizzoli

Brief Summary:
The purpose of this project is to present the outcomes of patients with giant cell tumor of bone (GCTB) who were treated with surgery and/or medical treatment in a single institution.

Condition or disease Intervention/treatment
Giant Cell Tumor of Bone Procedure: curettage and resection

Detailed Description:
The investigators retrospectively review patients treated for GCTB of the extremities between 1990 and 2013 in a single institution. We evaluate the recurrence free survival rate after surgical and medical treatment of patients with GCTB of the extremities to determine the influence of the surgical approach, denosumab therapy, local tumor presentation, and demographic factors on the risk of recurrence.

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Study Type : Observational
Actual Enrollment : 412 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Il Tumore a Cellule Giganti Delle estermità
Study Start Date : April 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Cancer
Drug Information available for: Denosumab


Intervention Details:
  • Procedure: curettage and resection
    the investigators analyzed patients with giant cell tumor of bone who underwent curettage or resection with or without denosumab administration
    Other Name: denosumab


Primary Outcome Measures :
  1. local recurrence rate after surgical and medical treatment [ Time Frame: within the first 36 months after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with giant cell tumor of bone treated in a single institution
Criteria

Inclusion Criteria:

  • giant cell tumors of the extremities

Exclusion Criteria:

  • giant cell tumors of the spine and pelvis

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): NCT02996734


Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
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Study Director: Davide Donati, MD Istituto Ortopedico Rizzoli

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Costantino Errani, MD; PhD., Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT02996734     History of Changes
Other Study ID Numbers: 0008286
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: publish a manuscript in international medical journal
Keywords provided by Costantino Errani, Istituto Ortopedico Rizzoli:
bone tumors
giant cell tumor
treatment
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
Musculoskeletal Diseases
Neoplasms, Bone Tissue
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs