Osteofibrous DysplasiaDOFOLNCT04104763
Osteofibrous Dysplasia (Kempson-Campanacci's Disease)
An observational study of Osteofibrous Dysplasia, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The aim of the present study is to obtain long term follow-up in patients with osteofibrous dysplasia, to assess natural history of the disease, late results of treatment and in particular the potential and risk of progression to adamantinoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteofibrous Dysplasia
- What is being tested?
- study of osteofibrous dysplasia features
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 8 Aug 2019to 30 Sep 2021
- 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: This is single institution cases series review of histological and clinical data
Who may be able to join
- Male and female patients treated at Rizzoli Institute from 01 Jan 1943 to 31 Dic 2011
- Diagnosis of osteofibrous dysplasia pathologically confirmed
- Written informed consent prior to any study-specific analysis and/or data collection
Who cannot join
- Patients with histological diagnosis different from osteofibrous dysplasia
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dept. of Pathology of IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136
About this study
Official title: Osteofibrous Dysplasia (Kempson-Campanacci's Disease): Long Term Follow-up Study on Natural History, Results of Treatment and Relationship With Adamantinoma
The aim of the present study is to obtain long term follow-up in patients with osteofibrous dysplasia, to assess natural history of the disease, late results of treatment and in particular the potential and risk of progression to adamantinoma.
- Conditions
- Osteofibrous Dysplasia
- Being tested
- study of osteofibrous dysplasia features
- Medical subject headings
- Osteofibrous Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
study of osteofibrous dysplasia featuresBehavioural
obtain long term follow-up in patients with osteofibrous dysplasia, to assess natural history of the disease, late results of treatment and in particular the potential and risk of progression to adamantinoma.
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteofibrous Dysplasia (Kempson-Campanacci's disease): Long Term Follow-up Study on Natural History, Results of Treatment and Relationship with Adamantinoma
We will retrieve from the database of the Rizzoli institute all the cases with a histological diagnosis of Ewing sarcoma from 01 Jan 1943 to 31 Dic 2011.
We aspect to find approximately 55 cases. We will review all the medical records, radiological imaging, and histological data of these cases.
Measured: BASELINE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start8 Aug 2019
- Primary completion30 Nov 2019
- Study completion30 Sep 2021
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 Osteofibrous DysplasiaStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Righi, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104763
- Sponsor's protocol ID
- 9261_2019
- Acronym
- DOFOL
- Status last verified
- Aug 2021
- First submitted
- 24 Sep 2019
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Benassi MS, Campanacci L, Gamberi G, Ferrari C, Picci P, Sangiorgi L, Campanacci M. Cytokeratin expression and distribution in adamantinoma of the long bones and osteofibrous dysplasia of tibia and fibula. An immunohistochemical study correlated to histogenesis. Histopathology. 1994 Jul;25(1):71-6. doi: 10.1111/j.1365-2559.1994.tb00600.x.
PubMed 7525449Scholfield DW, Sadozai Z, Ghali C, Sumathi V, Douis H, Gaston L, Grimer RJ, Jeys L. Does osteofibrous dysplasia progress to adamantinoma and how should they be treated? Bone Joint J. 2017 Mar;99-B(3):409-416. doi: 10.1302/0301-620X.99B3.38050.
PubMed 28249983Gleason BC, Liegl-Atzwanger B, Kozakewich HP, Connolly S, Gebhardt MC, Fletcher JA, Perez-Atayde AR. Osteofibrous dysplasia and adamantinoma in children and adolescents: a clinicopathologic reappraisal. Am J Surg Pathol. 2008 Mar;32(3):363-76. doi: 10.1097/PAS.0b013e318150d53e.
PubMed 18300815
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteofibrous Dysplasia (Kempson-Campanacci's Disease): Long Term Follow-up Study on Natural History, Results of Treatment and Relationship With Adamantinoma
- ClinicalTrials.gov ID
- NCT04104763
- Acronym / sponsor ID
- DOFOL / 9261_2019
- Conditions
- Osteofibrous Dysplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 26 Sep 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.
The aim of the present study is to obtain long term follow-up in patients with osteofibrous dysplasia, to assess natural history of the disease, late results of treatment and in particular the potential and risk of progression to adamantinoma.
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
- This is single institution cases series review of histological and clinical data
Key inclusion criteria (3 listed)
- Male and female patients treated at Rizzoli Institute from 01 Jan 1943 to 31 Dic 2011
- Diagnosis of osteofibrous dysplasia pathologically confirmed
- Written informed consent prior to any study-specific analysis and/or data collection
Key exclusion criteria (1 listed)
- Patients with histological diagnosis different from osteofibrous dysplasia
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 |
|---|---|---|
| study of osteofibrous dysplasia featuresobtain long term follow-up in patients with osteofibrous dysplasia, to assess natural history of the disease, late results of treatment and in particular the potential and risk of progression to adamantinoma. | Behavioural | – |
Primary outcome
Osteofibrous Dysplasia (Kempson-Campanacci's disease): Long Term Follow-up Study on Natural History, Results of Treatment and Relationship with Adamantinoma
Time frame: BASELINE
We will retrieve from the database of the Rizzoli institute all the cases with a histological diagnosis of Ewing sarcoma from 01 Jan 1943 to 31 Dic 2011. We aspect to find approximately 55 cases. We will review all the medical records, radiological imaging, and histological data of these cases.
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 23 Aug 2022.
- Results publication: PubMed 7525449Benassi MS, Campanacci L, Gamberi G, Ferrari C, Picci P, Sangiorgi L, Campanacci M. Cytokeratin expression and distribution in adamantinoma of the long bones and osteofibrous dysplasia of tibia and fibula. An immunohistochemical study correlated to histogenesis. Histopathology. 1994 Jul;25(1):71-6. doi: 10.1111/j.1365-2559.1994.tb00600.x.
- Results publication: PubMed 28249983Scholfield DW, Sadozai Z, Ghali C, Sumathi V, Douis H, Gaston L, Grimer RJ, Jeys L. Does osteofibrous dysplasia progress to adamantinoma and how should they be treated? Bone Joint J. 2017 Mar;99-B(3):409-416. doi: 10.1302/0301-620X.99B3.38050.
- Results publication: PubMed 18300815Gleason BC, Liegl-Atzwanger B, Kozakewich HP, Connolly S, Gebhardt MC, Fletcher JA, Perez-Atayde AR. Osteofibrous dysplasia and adamantinoma in children and adolescents: a clinicopathologic reappraisal. Am J Surg Pathol. 2008 Mar;32(3):363-76. doi: 10.1097/PAS.0b013e318150d53e.
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 Osteofibrous Dysplasia, 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 3 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 23 Aug 2022. 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?
Osteofibrous Dysplasia (Kempson-Campanacci's disease): Long Term Follow-up Study on Natural History, Results of Treatment and Relationship with Adamantinoma (time frame: BASELINE). 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 NCT04104763, 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 23 Aug 2022.