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Osteofibrous Dysplasia (Kempson-Campanacci's Disease) (DOFOL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04104763
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Alberto Righi, Istituto Ortopedico Rizzoli

Brief 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.

Condition or disease Intervention/treatment
Osteofibrous Dysplasia Behavioral: study of osteofibrous dysplasia features

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Study Type : Observational
Estimated Enrollment : 55 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Osteofibrous Dysplasia (Kempson-Campanacci's Disease): Long Term Follow-up Study on Natural History, Results of Treatment and Relationship With Adamantinoma
Actual Study Start Date : August 8, 2019
Actual Primary Completion Date : November 30, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: study of osteofibrous dysplasia features
    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.


Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This is single institution cases series review of histological and clinical data
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients with histological diagnosis different from osteofibrous dysplasia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04104763


Contacts
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Contact: ALBERTO RIGHI, MD PhD +39-051-636 ext 6665 alberto.righi@ior.it

Locations
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Italy
Dept. of Pathology of IRCCS Istituto Ortopedico Rizzoli Recruiting
Bologna, Italy, 40136
Contact: Alberto Righi, MD    +39051.63.66 ext 665    alberto.righi@ior.it   
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
  Study Documents (Full-Text)

Documents provided by Alberto Righi, Istituto Ortopedico Rizzoli:
Study Protocol  [PDF] May 22, 2019

Publications of Results:
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Responsible Party: Alberto Righi, Principal Investigator, Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT04104763    
Other Study ID Numbers: 9261_2019
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases