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

NCT ID: NCT02996734

Last Updated: 2016-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

412 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Giant Cell Tumor of Bone

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

bone tumors giant cell tumor treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

curettage and resection

the investigators analyzed patients with giant cell tumor of bone who underwent curettage or resection with or without denosumab administration

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

denosumab

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* giant cell tumors of the extremities

Exclusion Criteria

* giant cell tumors of the spine and pelvis
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Costantino Errani

MD; PhD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Davide Donati, MD

Role: STUDY_DIRECTOR

Istituto Ortopedico Rizzoli

References

Explore related publications, articles, or registry entries linked to this study.

Tsukamoto S, Mavrogenis AF, Leone G, Righi A, Akahane M, Tanzi P, Kido A, Honoki K, Tanaka Y, Donati DM, Errani C. Denosumab does not decrease the risk of lung metastases from bone giant cell tumour. Int Orthop. 2019 Feb;43(2):483-489. doi: 10.1007/s00264-018-4085-6. Epub 2018 Aug 11.

Reference Type DERIVED
PMID: 30099641 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0008286

Identifier Type: -

Identifier Source: org_study_id