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NCT00852943 · ClinicalTrials.gov registry record
Screening Protocol for Genetic Diseases of Allergic Inflammation
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 824
- Enrollment target
NCT00852943: Completed study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00852943 is a clinical trial that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 824 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00852943 has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 824 participants
- Enrollment target
Study Summary
Background: * Mast cells are responsible for most symptoms of allergic reactions. In some allergic diseases, it is unusually easy to cause mast cells to release their contents and cause allergic reactions. In other cases, mast cells grow abnormally and, in rare cases, can result in tumors. Mast cells also control other parts of the immune system. * Understanding why mast cells behave abnormally in allergic diseases is important to finding better ways for diagnosing and treating these potentially life-threatening disorders. Objectives: * To screen mast cells at the genetic and functional levels to characterize abnormalities, identify mutations, detect carrier states, and/or develop therapies for such disorders. * To create a library of information about inherited diseases of mast cell homeostasis and activation, including piebaldism (problems with skin and hair pigmentation), anaphylaxis (severe allergic reaction), allergies, asthma, atopic dermatitis (eczema), allergic rhinitis ( hay fever ), food allergies, urticaria/angioedema (hives/swelling), immunodeficiency diseases, and autoimmune diseases. Eligibility: * Patients between the ages of 1 and 80 years who have been referred by a physician and are known to have or be suspected of having an inherited disorder of mast cells, in particular patients (and their relatives) with piebaldism, allergies, or anaphylaxis that is not caused by allergies. Design: * Study population will consist of up to 1000 participants in a 5-year period. One third of the study population will consist of patients; the other two thirds will consist of biological relatives. * Evaluation is limited to testing on blood specimens; no treatment will be provided. * Clinical and research laboratory evaluations of patients will include the following: * Clinical evaluation and previous laboratory tests as documented in outside medical records by health care providers. A standard questionnaire will also be administered at the time of subject enr
Primary Outcome
Association of single gene mutations which are deemed causal with specific syndromic presentations of allergic disease, including atopic dermatitis, asthma, food allergy, eosinophilic disease, urticaria anaphylaxis, angioedema, IgE levels and changes to allergy-related effector cells.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 824 participants |
| Start Date | 2010-11-02 |
What the finished NCT00852943 record still lists
NCT00852943 is an observational study that tracks outcomes without assigning an intervention. The registered 824 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00852943 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00852943 about?
NCT00852943 is a clinical study titled "Screening Protocol for Genetic Diseases of Allergic Inflammation". Background: * Mast cells are responsible for most symptoms of allergic reactions. In some allergic diseases, it is unusually easy to cause mast cells to release their contents and cause allergic reactions. In other cases, mast cells grow abnormally and, in rare cases, can result in tumors. Mast cel...
What is the current status of trial NCT00852943?
This trial is currently completed. The enrollment target is 824 participants. The study started on 2010-11-02.
Who is sponsoring clinical trial NCT00852943?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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