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NCT02996734 Clinical Trial

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

Giant Cell Tumor of Bone Clinical Trial

— GCTLIMBS  

Official title:
Il Tumore a Cellule Giganti Delle estermità

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02996734
Other study ID # 0008286
Secondary ID
Status Completed
Phase N/A
First received December 15, 2016
Last updated December 21, 2016
Start date April 2016
Est. completion date December 2016

Study information
Verified date December 2016
Source Istituto Ortopedico Rizzoli
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 412
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- giant cell tumors of the extremities

Exclusion Criteria:

- giant cell tumors of the spine and pelvis

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Istituto Ortopedico Rizzoli

Outcome
Type Measure Description Time frame Safety issue
Primary local recurrence rate after surgical and medical treatment within the first 36 months after surgery Yes
See also
  Status Clinical Trial Phase
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Active, not recruiting NCT04255576 - Efficacy and Safety of JMT103 in Patients With Giant Cell Tumor of Bone Phase 1/Phase 2
Completed NCT03301857 - Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004 Phase 4
Completed NCT05402865 - A Real-world Study on Patients of Unresectable Giant Cell Tumor of Bone
Recruiting NCT03295981 - Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone Phase 3
Completed NCT00464620 - Trial of Dasatinib in Advanced Sarcomas Phase 2
Recruiting NCT03259152 - Characteristics and Mechanism of Denosumab-treated Giant Cell Tumor of Bone Phase 3
Recruiting NCT05595603 - Zoledronic Acid-loaded Bone Cement as a Local Adjuvant Therapy for Giant Cell Bone Tumor After Intralesional Curettage Phase 2
Not yet recruiting NCT03358212 - Safety and Efficacy of Post-operative Denosumab Strategy for Giant Cell Tumor of Bone Treatment in China N/A
Completed NCT04002817 - Giant Cell Tumor of the Bone in Young Patients
Completed NCT00396279 - Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone Phase 2
Terminated NCT00889590 - Adjuvant Zoledronic Acid in High Risk Giant Cell Tumour of Bone (GCT) Phase 2
Recruiting NCT04586660 - Study of XGEVA® (Denosumab) in Chinese Adults and Skeletally Mature Adolescents With Giant Cell Tumor of the Bone Phase 4
Active, not recruiting NCT03449108 - LN-145 or LN-145-S1 in Treating Patients With Relapsed or Refractory Ovarian Cancer, Triple Negative Breast Cancer (TNBC), Anaplastic Thyroid Cancer, Osteosarcoma, or Other Bone and Soft Tissue Sarcomas Phase 2
Not yet recruiting NCT05813665 - A Study to Evaluate the Efficacy and Safety of Narlumosbart (JMT103) in Patients With Giant Cell Tumor of Bone Phase 3