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Clinical Trials/NCT01326741
NCT01326741UnknownNot Applicable

Detection of Clonal Mast Cell Disorders Among Patients With Exercise-induced Anaphylaxis

Brigham and Women's Hospital1 site in 1 country10 target enrollmentStarted: March 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
10
Locations
1
Primary Endpoint
Number of participants with presence of clonal abnormalities in the bone marrow specimen

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • Pregnancy

Outcomes

Primary Outcomes

Number of participants with presence of clonal abnormalities in the bone marrow specimen

Time Frame: Baseline

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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