Natural History of Cherubism Observational Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01916772
First received: July 25, 2013
Last updated: August 2, 2013
Last verified: August 2013
  Purpose

To observe the natural history of cherubism.


Condition Intervention
Cherubism
Other: no interventions

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural Hisotry of Cherubism Observational Study

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Disease progression [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    We will take a history and examine patients with cherubism and look for disease progression.


Secondary Outcome Measures:
  • patient growth [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    We will measure height and weight

  • bone abnormalities [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    We will take panorex radiographs.


Biospecimen Retention:   Samples With DNA

We may take blood or skin samples.


Estimated Enrollment: 100
Study Start Date: July 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
cherubism patients
no interventions
Other: no interventions
no interventions

Detailed Description:

The investigators will take a history and examine patients with cherubism to determine the natural history of the disease. The investigators also may take skin or blood samples (IRB approved 7256) from patients to learn more about this disorder.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

We will see patients with cherubism

Criteria

Inclusion Criteria:

patients with cherubism

Exclusion Criteria:

patients without cherubism

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01916772

Contacts
Contact: Steven Lietman 2168702475 lietmas@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Steven A Lietman, MD    216-445-2742    lietmas@ccf.org   
Principal Investigator: Steven A Lietman, MD         
Sponsors and Collaborators
The Cleveland Clinic
  More Information

Publications:
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01916772     History of Changes
Other Study ID Numbers: CCFO7256
Study First Received: July 25, 2013
Last Updated: August 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
cherubism
bone tumors

Additional relevant MeSH terms:
Fibrous Dysplasia of Bone
Cherubism
Bone Diseases
Bone Diseases, Developmental
Congenital Abnormalities
Craniofacial Abnormalities
Genetic Diseases, Inborn
Jaw Diseases
Maxillofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Osteochondrodysplasias
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 29, 2014