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

December 21, 2016 updated by: Costantino Errani, Istituto Ortopedico Rizzoli

Il Tumore a Cellule Giganti Delle estermità

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

412

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with giant cell tumor of bone treated in a single institution

Description

Inclusion Criteria:

  • giant cell tumors of the extremities

Exclusion Criteria:

  • giant cell tumors of the spine and pelvis

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
local recurrence rate after surgical and medical treatment
Time Frame: within the first 36 months after surgery
within the first 36 months after surgery

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

April 1, 2016

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

December 15, 2016

First Submitted That Met QC Criteria

December 16, 2016

First Posted (ESTIMATE)

December 19, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 22, 2016

Last Update Submitted That Met QC Criteria

December 21, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0008286

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

publish a manuscript in international medical journal

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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