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Histamine Responsiveness in McCune-Albright Syndrome
NCT00318097 · View on ClinicalTrials.gov ↗
Study Summary
McCune-Albright syndrome (MAS) is a syndrome caused by a genetic mutation that causes a specific protein in the body called a G protein to be constantly active. Children with McCune-Albright syndrome classically have early puberty, areas of increased skin pigmentation, and bone lesions resulting from the constant activity of the specific protein involved. Histamines are known to play a role in allergies and related allergic problems. The effects of histamines are controlled by the same G protein that is overly active in McCune-Albright syndrome. Thus, one could predict that patients with McCune-Albright may be at high risk for allergic problems. To date, no studies have documented any form of histamine excess or allergic difficulties in patients with McCune-Albright syndrome. However, the investigators have made the observation that a high percentage of their patients with MAS exhibit a range of allergic symptoms, from mild symptoms, to severe, life-threatening symptoms. The purpose of this study is to demonstrate increased histamine response by using a histamine skin test in patients with MAS. If increased reactions to histamines can be documented in MAS patients when compared to controls, severe and potentially life threatening allergic reactions in children with MAS could be anticipated and avoided.
Conditions Studied
Study Locations (1)
Missouri
- Children's Mercy Hospitals and Clinics — Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2004-08-01 |
| Est. Completion | 2007-08-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00318097
The ClinicalTrials.gov registry entry for NCT00318097 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Mercy Hospital Kansas City, which has 93 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with McCune-Albright Syndrome appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00318097 reports 1 study location spanning 1 distinct geographic area — top geographies include Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00318097 about?
NCT00318097 is a clinical study titled "Histamine Responsiveness in McCune-Albright Syndrome". McCune-Albright syndrome (MAS) is a syndrome caused by a genetic mutation that causes a specific protein in the body called a G protein to be constantly active. Children with McCune-Albright syndrome classically have early puberty, areas of increased skin pigmentation, and bone lesions resulting fro...
What is the current status of trial NCT00318097?
This trial is currently completed. The enrollment target is 22 participants. The study started on 2004-08-01. Estimated completion is 2007-08-01.
What conditions does trial NCT00318097 study?
This clinical trial studies the following conditions: McCune-Albright Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT00318097?
This trial is sponsored by Children's Mercy Hospital Kansas City, which has 93 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00318097 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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