Osteofibrous Dysplasia (Kempson-Campanacci's Disease)

Osteofibrous Dysplasia Clinical Trial

— DOFOL  

Official title:

Osteofibrous Dysplasia (Kempson-Campanacci's Disease): Long Term Follow-up Study on Natural History, Results of Treatment and Relationship With Adamantinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04104763
• Other study ID #: 9261_2019
• Status: Completed
• Start date: August 8, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: August 2021
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 30, 2021
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Developmental
• Osteofibrous Dysplasia

Intervention

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.

Locations

Country	Name	City	State
Italy	Dept. of Pathology of IRCCS Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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 histog — View Citation

Gleason 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: 10.109 — View Citation

Scholfield 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	BASELINE