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NCT00314119 · ClinicalTrials.gov registry record
Natural History and Biology of Skin Neurofibromas in Neurofibromatosis Type 1
A clinical trial, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 17
- Enrollment target
NCT00314119: Completed study, sponsored by National Cancer Institute (NCI).
NCT00314119 is a clinical trial that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 17 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00314119 has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 17 participants
- Enrollment target
Study Summary
This study will explore the growth of dermal neurofibromas (skin tumors) in patients with neurofibromatosis type 1 (NF1). Investigators will try to learn: 1) how fast (or slow) these benign tumors grow in NF1, 2) how often new tumors appear and 3) what genes are involved in the growth of the tumors. Men and women between 20 and 50 years of age diagnosed with NF1 and their biological parents are eligible for this study. Patients with NF1 are evaluated at the NIH Clinical Center with the following tests and procedures: * Medical examination and drawing of family tree. * Photos of the back, abdomen and thigh in order to count the number of skin tumors. * Photos of the skin taken with a special camera (Primos camera) that takes very detailed pictures of a small area of skin. * Photos of the skin taken with a dermatoscope, which takes very detailed pictures of a small area of skin under high magnification. * Biopsy of at least one skin tumor and biopsy of a small piece of normal skin. * Blood sample collection for genetic testing of the gene NF1 and to establish a cell line. * Other medical tests (e.g., x-rays or MRI) if needed. Patients and their families will also have a genetic counseling session and an opportunity to ask questions about neurofibromatosis type 1. Patients return to the NIH after 3, 6, 12, 18 and 24 months for follow-up photographs and possibly blood samples. Biological parents of patients provide a blood sample for genetic testing.
Primary Outcome
Evaluate the natural history of dermal neurofibromas in NF1 by monitoring the growth rate and development of new dermal neurofibromas using three different complementary imaging modalities over time in individuals with NF1. The study will be adequately powered so that a minimally meaningful statistical definition of progression can be developed for use in subsequent treatment protocols.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2006-06-08 |
What the finished NCT00314119 record still lists
NCT00314119 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 17 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00314119 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00314119 about?
NCT00314119 is a clinical study titled "Natural History and Biology of Skin Neurofibromas in Neurofibromatosis Type 1". This study will explore the growth of dermal neurofibromas (skin tumors) in patients with neurofibromatosis type 1 (NF1). Investigators will try to learn: 1) how fast (or slow) these benign tumors grow in NF1, 2) how often new tumors appear and 3) what genes are involved in the growth of the tumors....
What is the current status of trial NCT00314119?
This trial is currently completed. The enrollment target is 17 participants. The study started on 2006-06-08.
Who is sponsoring clinical trial NCT00314119?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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