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NCT01776125 · ClinicalTrials.gov registry record
Genetic Evaluation of NF1 and Scoliosis Patients
A clinical trial, sponsored by University of Minnesota.
- Completed
- Registry status
- 59
- Enrollment target
NCT01776125: Completed study, sponsored by University of Minnesota.
NCT01776125 is a clinical trial that has completed, run by University of Minnesota. The registered enrollment target is 59 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01776125 has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- 59 participants
- Enrollment target
Study Summary
Neurofibromatosis (NF) is a common genetic disorder that cause tumors to grow along various types of nerves and, in addition, can affect the development of bones and skin. It occurs in 1:4000 persons. NF has been classified into three distinct types: NF1, NF2 and Schwannomatosis. NF1 is the focus of this study. NF1 is an extremely variable disorder which ranges from extremely mild cases in which the only signs of the disorder in adulthood may be multiple café-au-lait spots and a few dermal neurofibromas, to more severe cases like disfigurement, scoliosis and learning disabilities. Scoliosis (abnormal curvature of the spine) is perhaps the most common bone deformity in NF1 which usually appears in early childhood. There are two types: dystrophic and non-dystrophic scoliosis. Dystrophic scoliosis is usually associated with other bone deformities which are seen on x-ray and carries a poorer prognosis than non dystrophic scoliosis. There is evidence that genes other than the NF1 gene are responsible for the variable severity of cases. Recent studies have identified genetic markers for another condition called adolescent idiopathic scoliosis (scoliosis which presents in adolescent age group with no known cause). We believe that the same genetic markers may also be present in NF1 patients with scoliosis. Our objective is primarily to determine if the same genetic markers discovered in adolescent idiopathic scoliosis are also present in NF1 patients with scoliosis.
Primary Outcome
The SCOLISCORE Test is the first and only genetic test proven to give physicians and parents insight into the possible progression of patient with Adolescent Idiopathic Scoliosis (AIS), thereby reducing the uncertainty of AIS progression.
Interventions
- OTHER Cheek swab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2010-08 |
| Est. Completion | 2015-08 |
What the finished NCT01776125 record still lists
NCT01776125 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 59 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Cheek swab is the first listed.
NCT01776125 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01776125 about?
NCT01776125 is a clinical study titled "Genetic Evaluation of NF1 and Scoliosis Patients". Neurofibromatosis (NF) is a common genetic disorder that cause tumors to grow along various types of nerves and, in addition, can affect the development of bones and skin. It occurs in 1:4000 persons. NF has been classified into three distinct types: NF1, NF2 and Schwannomatosis. NF1 is the focus of...
What is the current status of trial NCT01776125?
This trial is currently completed. The enrollment target is 59 participants. The study started on 2010-08. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01776125?
The interventions under investigation include: Cheek swab (OTHER).
Who is sponsoring clinical trial NCT01776125?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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