Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Natural History of Cherubism Observational Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by The Cleveland Clinic.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
The Cleveland Clinic Identifier:
First received: July 25, 2013
Last updated: August 2, 2013
Last verified: August 2013
To observe the natural history of cherubism.

Condition Intervention
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.

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
We will see patients with cherubism

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 identifier: NCT01916772

United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
  More Information

Responsible Party: The Cleveland Clinic 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:
bone tumors

Additional relevant MeSH terms:
Fibrous Dysplasia of Bone
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Jaw Diseases
Stomatognathic Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn processed this record on December 08, 2016