Giant Cell Tumor of BoneNCT04002817
Giant Cell Tumor of the Bone in Young Patients
An observational study of Giant Cell Tumor of Bone, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
single institution cases series review of histological and clinical data of young patient with Giant Cell Tumors Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Giant Cell Tumor of Bone
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- 5 Jun 2019to 30 Jun 2020
- 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 Up to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: young patients with giant cell tumor of bone
Who may be able to join
- Male and female patients under 15 years old treated at Rizzoli Institute from 01 January 1982 to 31 December 2018.
- Diagnosis of giant cell tumor of bone, aneurysmatic bone cysts with solid features and giant cell reparative granuloma.
- Histological slides/formalin-fixed paraffin-embedded tissue tumor blocks from archive available to perform the histology analysis
- Written informed consent prior to any study-specific analysis and/or data collection
Who cannot join
- Patients with histological diagnosis different from diagnosis of giant cell tumor, aneurysmatic bone cysts with solid features, and giant cell reparative granuloma.
- Patients with no available material for additional immunohistochemical and molecular analysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Giant Cell Tumor of the Bone in Patients Under 15 Years Old: a Single Institution Case-series
single institution cases series review of histological and clinical data of young patient with Giant Cell Tumors
- Conditions
- Giant Cell Tumor of Bone
- Medical subject headings
- Giant Cell Tumor of Bone
What is being measured
The primary outcome is the main question the study is designed to answer.
selection and review of 50 cases of young patients with Giant Cell Tumor of bone.
Investigators will review all the medical records, radiological imaging, and histological slides of all cases in order to collect the largest pediatric series.
Measured: at baseline (Day0)
Secondary outcomes (1)
analysis of H3F3A mutation expression on tissue tumor material
In all cases with enough available material, immunohistochemistry will be performed on tumor tissue material. Histone 3.3 (H3.3) genes, and H3F3A mutation will be analyzed with immunohistochemistry and/or by allele specific-PCR analysis in order to confirm that the lesions are a giant cell tumors of bone occurring in a non-canonic age group (skeletally immature patients).
Measured: at baseline (Day0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start5 Jun 2019
- Primary completion30 Dec 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002817
- Sponsor's protocol ID
- Pediatric GCTB
- Status last verified
- Jun 2019
- First submitted
- 25 Jun 2019
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Campanacci M, Baldini N, Boriani S, Sudanese A. Giant-cell tumor of bone. J Bone Joint Surg Am. 1987 Jan;69(1):106-14.
PubMed 3805057Al-Ibraheemi A, Inwards CY, Zreik RT, Wenger DE, Jenkins SM, Carter JM, Boland JM, Rose PS, Jin L, Oliveira AM, Fritchie KJ. Histologic Spectrum of Giant Cell Tumor (GCT) of Bone in Patients 18 Years of Age and Below: A Study of 63 Patients. Am J Surg Pathol. 2016 Dec;40(12):1702-1712. doi: 10.1097/PAS.0000000000000715.
PubMed 27526293Dahlin DC, Cupps RE, Johnson EW Jr. Giant-cell tumor: a study of 195 cases. Cancer. 1970 May;25(5):1061-70. doi: 10.1002/1097-0142(197005)25:53.0.co;2-e. No abstract available.
PubMed 4910256
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Giant Cell Tumor of the Bone in Patients Under 15 Years Old: a Single Institution Case-series
- ClinicalTrials.gov ID
- NCT04002817
- Acronym / sponsor ID
- Pediatric GCTB
- Conditions
- Giant Cell Tumor of Bone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 1 Jul 2019 (actual)
- 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.
single institution cases series review of histological and clinical data of young patient with Giant Cell Tumors
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- young patients with giant cell tumor of bone
Key inclusion criteria (4 listed)
- Male and female patients under 15 years old treated at Rizzoli Institute from 01 January 1982 to 31 December 2018.
- Diagnosis of giant cell tumor of bone, aneurysmatic bone cysts with solid features and giant cell reparative granuloma.
- Histological slides/formalin-fixed paraffin-embedded tissue tumor blocks from archive available to perform the histology analysis
- Written informed consent prior to any study-specific analysis and/or data collection
Key exclusion criteria (2 listed)
- Patients with histological diagnosis different from diagnosis of giant cell tumor, aneurysmatic bone cysts with solid features, and giant cell reparative granuloma.
- Patients with no available material for additional immunohistochemical and molecular analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
selection and review of 50 cases of young patients with Giant Cell Tumor of bone.
Time frame: at baseline (Day0)
Investigators will review all the medical records, radiological imaging, and histological slides of all cases in order to collect the largest pediatric series.
1 secondary outcome
analysis of H3F3A mutation expression on tissue tumor material
Time frame: at baseline (Day0)
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 4 May 2021.
- Results publication: PubMed 3805057Campanacci M, Baldini N, Boriani S, Sudanese A. Giant-cell tumor of bone. J Bone Joint Surg Am. 1987 Jan;69(1):106-14.
- Results publication: PubMed 27526293Al-Ibraheemi A, Inwards CY, Zreik RT, Wenger DE, Jenkins SM, Carter JM, Boland JM, Rose PS, Jin L, Oliveira AM, Fritchie KJ. Histologic Spectrum of Giant Cell Tumor (GCT) of Bone in Patients 18 Years of Age and Below: A Study of 63 Patients. Am J Surg Pathol. 2016 Dec;40(12):1702-1712. doi: 10.1097/PAS.0000000000000715.
- Results publication: PubMed 4910256Dahlin DC, Cupps RE, Johnson EW Jr. Giant-cell tumor: a study of 195 cases. Cancer. 1970 May;25(5):1061-70. doi: 10.1002/1097-0142(197005)25:53.0.co;2-e. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Cell Tumor of Bone, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 4 inclusion and 2 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 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
selection and review of 50 cases of young patients with Giant Cell Tumor of bone. (time frame: at baseline (Day0)). 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 NCT04002817, which also lists 3 linked publications.
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 4 May 2021.