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NCT00111384 · ClinicalTrials.gov registry record
Study of Disease Severity in Adults With Neurofibromatosis Type 1 (NF1)
A clinical trial, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 313
- Enrollment target
NCT00111384: Completed study, sponsored by National Cancer Institute (NCI).
NCT00111384 is a clinical trial that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 313 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00111384 has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 313 participants
- Enrollment target
Study Summary
This study may identify genes that predict the seriousness of neurofibromatosis type 1 (NF1). Finding these genes may explain why some people with NF1 have more medical problems than others. The study will also examine medical problems in NF1 that are rarely seen and are not well understood. Male and female patients with NF1 who have gone through puberty may be eligible for this study, as well as patients of any age who have unique or under-recognized disease features. Affected and unaffected family members, including parents, siblings, and more distant relatives, may also be enrolled. Candidates are screened with a discussion of medical history or review of medical records, or both. Participants undergo the following procedures: Patients with NF1 * Physical examination and family history * Photographs of the iris of each eye * Photographs of the back, abdomen and thigh to count skin tumors * Photographs of the face and body (with underwear on) to help track growth and appearance * Magnetic resonance imaging (MRI) of the spine (This test uses a magnetic field and radio waves to look for tumors and curvature of the spine. The patient lies still in the scanner, a narrow cylindrical device, wearing earplugs to muffle loud knocking sounds that occur during the scan. A contrast material called gadolinium is injected into a vein through a catheter to enhance the images.) * Blood draw for genetic studies * Possibly a skin biopsy (with the use of numbing medicine, removal of a small sample of skin tissue) to grow cells in the laboratory Patients with NF1 who have unique or under-recognized disease features * Physical examination and family history * Blood draw for genetic studies * Possibly a skin biopsy * Possibly additional tests, such as blood work, x-rays, photographs, MRIs, ultrasounds, or other tests Unaffected family members * Blood draw for genetic studies * Brief skin and eye examinations * Possibly a skin biopsy for cell culture Families are asked to give
Primary Outcome
Phenotype severityPhenotype individuals and family members affected with NF1 by routine history and physical. The primary (spinal neurofibroma burden) and secondary (dermal neurofibroma burden, head circumference, number of Lisch nodules, scoliosis, history of plexiform neurofibromas, height) sub- phenotypes will be quantified with as appropriate technology (MRI, iris exam and photography, physical exam, medical history).
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 313 participants |
| Start Date | 2005-07-27 |
What the finished NCT00111384 record still lists
NCT00111384 is an observational study that tracks outcomes without assigning an intervention. The registered 313 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00111384 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00111384 about?
NCT00111384 is a clinical study titled "Study of Disease Severity in Adults With Neurofibromatosis Type 1 (NF1)". This study may identify genes that predict the seriousness of neurofibromatosis type 1 (NF1). Finding these genes may explain why some people with NF1 have more medical problems than others. The study will also examine medical problems in NF1 that are rarely seen and are not well understood. Male a...
What is the current status of trial NCT00111384?
This trial is currently completed. The enrollment target is 313 participants. The study started on 2005-07-27.
Who is sponsoring clinical trial NCT00111384?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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