Clonal Mast Cell Disorders in Exercise-Induced Anaphylaxis
Detection of Clonal Mast Cell Disorders Among Patients With Exercise-induced Anaphylaxis
1 other identifier
observational
10
1 country
1
Brief Summary
Anaphylaxis is a serious allergic reaction that develops rapidly and can cause death. Some patients experience anaphylaxis is association with exercise, a disorder called exercise-induced anaphylaxis. A subset of patients with unexplained anaphylaxis, especially those with hypotension during the anaphylactic episodes, have been shown to have abnormal, clonal populations of a certain cell type, mast cells, in the bone marrow. This has been described in at least one patient with exercise-induced anaphylaxis. The investigators would like review the findings in a group of patients with exercise-induced anaphylaxis who have undergone evaluation for the presence of abnormal, clonal mast cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 29, 2011
CompletedFirst Posted
Study publicly available on registry
March 31, 2011
CompletedMarch 31, 2011
March 1, 2011
March 29, 2011
March 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of participants with presence of clonal abnormalities in the bone marrow specimen
Presence of clonal mast cells in bone marrow as assessed by D816V c-kit mutation or CD25 will be recorded for each participant.
Baseline
Number of participants with presence of clonal abnormalities in the bone marrow specimen
Presence of clonal mast cells in bone marrow as assessed by D816V c-kit mutation or CD25 will be recorded for each participant. The data will be reported as the number of participant with exercise induced anaphylaxis carrying these clonal mast cells in this observational study. Presence of mast cells will be correlated with clinical parameters such as symptoms experienced during anapylaxis.
Baseline
Eligibility Criteria
Ten adults of either sex
You may qualify if:
- Anaphylaxis in association with exercise on at least two occasions
- During anaphylactic reaction, the subject must have experienced one or more of the following: flushing, hypotension, lack of urticaria
You may not qualify if:
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (1)
Akin C, Scott LM, Kocabas CN, Kushnir-Sukhov N, Brittain E, Noel P, Metcalfe DD. Demonstration of an aberrant mast-cell population with clonal markers in a subset of patients with "idiopathic" anaphylaxis. Blood. 2007 Oct 1;110(7):2331-3. doi: 10.1182/blood-2006-06-028100. Epub 2007 Jul 16.
PMID: 17638853BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 29, 2011
First Posted
March 31, 2011
Study Start
March 1, 2011
Last Updated
March 31, 2011
Record last verified: 2011-03