Status:
COMPLETED
Neurofibromatosis Type 1 (NF1) and Tibial Dysplasia
Lead Sponsor:
Shriners Hospitals for Children
Collaborating Sponsors:
University of Utah
Conditions:
Neurofibromatosis Type 1
Tibial Dysplasia
Eligibility:
All Genders
Brief Summary
The study is a multicenter four-year outcome study of the natural history of tibial dysplasia in patients with NF1 and selected patients without NF1. We will obtain information on the natural history,...
Detailed Description
The three specific aims of this study are: * Specific Aim 1 - To assess health status and health - related quality of life (HRQL) in 50 children and adolescents with NF1 and tibial dysplasia and in N...
Eligibility Criteria
Inclusion
- Aim 1:
- Group 1, NF1 with Tibial Dysplasia, Ages: 3-18
- Group 2 (control), NF1 without Tibial Dysplasia, Ages 3-18
- Aim 2: NF1 with Tibial Dysplasia, 19+
- Aim 3: Tibial Dysplasia with or without NF1, Ages: birth to 18
- Tissue procurement, any participant undergoing surgery at the tibial site for routine standard of care
Exclusion
- Patients without a diagnosis of NF1 or Tibial Dysplasia
Key Trial Info
Start Date :
March 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
395 Patients enrolled
Trial Details
Trial ID
NCT00303368
Start Date
March 1 2004
End Date
January 1 2016
Last Update
February 25 2019
Active Locations (1)
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1
Shriners Hospitals for Children, Intermountain Hospital
Salt Lake City, Utah, United States, 84103