Giant Cell Tumor of BoneGCTLIMBSNCT02996734
Giant Cell Tumor of the Extremities Treated With Surgery and/or Medical Treatment
An observational study of Giant Cell Tumor of Bone, run by Istituto Ortopedico Rizzoli.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Giant Cell Tumor of Bone
- What is being tested?
- curettage and resection
- Type of treatment
- Surgery or procedure
- How many people
- 412 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with giant cell tumor of bone treated in a single institution
Who may be able to join
- giant cell tumors of the extremities
Who cannot join
- giant cell tumors of the spine and pelvis
About this study
Official title: 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.
Read the 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.
- Conditions
- Giant Cell Tumor of Bone
- Being tested
- curettage and resection
- Keywords
- bone tumors, giant cell tumor, treatment
- Medical subject headings
- Giant Cell Tumor of Bone, Bone Neoplasms, Giant Cell Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curettage and resectionProcedure or surgery
Also called denosumab
the investigators analyzed patients with giant cell tumor of bone who underwent curettage or resection with or without denosumab administration
What is being measured
The primary outcome is the main question the study is designed to answer.
local recurrence rate after surgical and medical treatment
Measured: within the first 36 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Giant Cell Tumor of BoneStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Costantino Errani, Istituto Ortopedico Rizzoli
- Investigators
- Davide Donati, MD, Study director, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996734
- Sponsor's protocol ID
- 0008286
- Acronym
- GCTLIMBS
- Status last verified
- Dec 2016
- First submitted
- 15 Dec 2016
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: publish a manuscript in international medical journal
Publications
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.
PubMed 30099641
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Il Tumore a Cellule Giganti Delle estermità
- ClinicalTrials.gov ID
- NCT02996734
- Acronym / sponsor ID
- GCTLIMBS / 0008286
- Conditions
- Giant Cell Tumor of Bone
- Keywords
- bone tumors, giant cell tumor, treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with giant cell tumor of bone treated in a single institution
Key inclusion criteria (1 listed)
- giant cell tumors of the extremities
Key exclusion criteria (1 listed)
- giant cell tumors of the spine and pelvis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| curettage and resectionAlso: denosumabthe investigators analyzed patients with giant cell tumor of bone who underwent curettage or resection with or without denosumab administration | Procedure or surgery | – |
Primary outcome
local recurrence rate after surgical and medical treatment
Time frame: within the first 36 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2016.
- Derived from this study: PubMed 30099641Tsukamoto 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.
- Individual participant dataSharing planned: Yes. publish a manuscript in international medical journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Davide Donati, MD study director
Istituto Ortopedico Rizzoli
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Cell Tumor of Bone, run by Istituto Ortopedico Rizzoli.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local recurrence rate after surgical and medical treatment (time frame: within the first 36 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02996734, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2016; AzTrials last refreshed its copy on 8 Nov 2026.