Epithelioid Hemangioma of BoneEE-METANCT03169595
Epithelioid Hemangioma of Bone And Soft Tissue
An observational study of Epithelioid Hemangioma of Bone and Epithelioid Hemangioma, run by Istituto Ortopedico Rizzoli.
Trial summary
The controversy surrounding epithelioid hemangioma diagnosis stems from its somewhat aggressive clinical characteristics, including multifocal presentation and occasional lymph node involvement. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epithelioid Hemangioma of Bone, Epithelioid Hemangioma
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 7 Oct 2015to 17 May 2017
- 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 epithelioid hemangioma of bone and soft tissue treated in a single institution
Who may be able to join
- patients with epithelioid hemangioma of bone and soft tissue in the extremities and pelvis
Who cannot join
- patients with epithelioid hemangioma of bone and soft tissue in the spine
About this study
Official title: Epithelioid Hemangioma of Bone And Soft Tissue: a Benign Tumor With Metastatic Potential
The controversy surrounding epithelioid hemangioma diagnosis stems from its somewhat aggressive clinical characteristics, including multifocal presentation and occasional lymph node involvement.
The investigators reviewed the clinicopathologic and radiologic characteristics of bone and soft tissue epithelioid hemangioma in patients treated at our institution with available tissue for molecular testing.
The hypothesis is that epithelioid hemangioma may present with multifocal involvement and rare loco-regional lymph node metastasis, but it remains a benign tumor with excellent prognosis.
Read the detailed description
The investigators retrospectively reviewed patients treated for epithelioid hemangioma of the bone and soft tissue in a single insitution. The purpose of this study is to evaluate the pathological, clinical, and radiological characteristics of epithelioid hemangioma arising within bone and soft tissue, in the first cohort of cases where the definitive diagnosis is supplemented by molecular techniques.
The hypothesis is that the improved knowledge regarding this rare entity can more definitively elucidate the benign biology of epithelioid hemangioma.
- Being tested
- Surgery
- Medical subject headings
- Angiolymphoid Hyperplasia with Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Patients affected by epithelioid hemangioma treated with surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Multifocal presentation of patients with epithelioid hemangioma of bone and soft tissue without producing a fatal outcome
The investigators defined multifocal presentation the presence of secondary lesions by imaging at presentation of the disease or during follow-up.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start7 Oct 2015
- Primary completion17 May 2017
- Study completion17 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelioid Hemangioma 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
- 70 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
- NCT03169595
- Sponsor's protocol ID
- 0033566
- Acronym
- EE-META
- Status last verified
- May 2017
- First submitted
- 17 May 2017
- Last updated
- 30 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: publish a manuscript in international journal
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epithelioid Hemangioma of Bone And Soft Tissue: a Benign Tumor With Metastatic Potential
- ClinicalTrials.gov ID
- NCT03169595
- Acronym / sponsor ID
- EE-META / 0033566
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 7 Oct 2015 (actual)
- Primary completion
- 17 May 2017 (actual)
- Study completion
- 17 May 2017 (actual)
- First posted
- 30 May 2017 (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.
The controversy surrounding epithelioid hemangioma diagnosis stems from its somewhat aggressive clinical characteristics, including multifocal presentation and occasional lymph node involvement.
The investigators reviewed the clinicopathologic and radiologic characteristics of bone and soft tissue epithelioid hemangioma in patients treated at our institution with available tissue for molecular testing.
The hypothesis is that epithelioid hemangioma may present with multifocal involvement and rare loco-regional lymph node metastasis, but it remains a benign tumor with excellent prognosis.
Detailed description
The investigators retrospectively reviewed patients treated for epithelioid hemangioma of the bone and soft tissue in a single insitution. The purpose of this study is to evaluate the pathological, clinical, and radiological characteristics of epithelioid hemangioma arising within bone and soft tissue, in the first cohort of cases where the definitive diagnosis is supplemented by molecular techniques.
The hypothesis is that the improved knowledge regarding this rare entity can more definitively elucidate the benign biology of epithelioid hemangioma.
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 epithelioid hemangioma of bone and soft tissue treated in a single institution
Key inclusion criteria (1 listed)
- patients with epithelioid hemangioma of bone and soft tissue in the extremities and pelvis
Key exclusion criteria (1 listed)
- patients with epithelioid hemangioma of bone and soft tissue in the spine
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 |
|---|---|---|
| SurgeryPatients affected by epithelioid hemangioma treated with surgery | Procedure or surgery | – |
Primary outcome
Multifocal presentation of patients with epithelioid hemangioma of bone and soft tissue without producing a fatal outcome
Time frame: 2 years
The investigators defined multifocal presentation the presence of secondary lesions by imaging at presentation of the disease or during follow-up.
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 30 May 2017.
- Individual participant dataSharing planned: Yes. publish a manuscript in international journal
Related trials for Epithelioid Hemangioma of Bone
RecruitingPhase 1/2
NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
Adipocytic Neoplasm, Liposarcoma
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 Epithelioid Hemangioma of Bone and Epithelioid Hemangioma, 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 30 May 2017. 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?
Multifocal presentation of patients with epithelioid hemangioma of bone and soft tissue without producing a fatal outcome (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2017.