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

• Sponsor: Istituto Ortopedico Rizzoli (Other)
• Overall Status: Completed
• CT.gov ID: NCT02996734
• Collaborator: (none)
• Enrollment: 412
• Duration (Months): 8

Study Details

Study Description

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	Phase
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.

Study Design

• 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: Apr 1, 2016
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Outcome Measures

Primary Outcome Measures

1. local recurrence rate after surgical and medical treatment [within the first 36 months after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• giant cell tumors of the extremities

Exclusion Criteria:

• giant cell tumors of the spine and pelvis

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Istituto Ortopedico Rizzoli

Investigators

• Study Director: Davide Donati, MD, Istituto Ortopedico Rizzoli

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Costantino Errani, MD; PhD., Istituto Ortopedico Rizzoli
• ClinicalTrials.gov Identifier: NCT02996734
• Other Study ID Numbers: 0008286
• First Posted: Dec 19, 2016
• Last Update Posted: Dec 22, 2016
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Costantino Errani, MD; PhD., Istituto Ortopedico Rizzoli: bone tumors; giant cell tumor; treatment
• Additional relevant MeSH terms: Giant Cell Tumors; Bone Neoplasms; Giant Cell Tumor of Bone; Denosumab

Study Results

No Results Posted as of Dec 22, 2016