Clonal Mast Cell Disorders in Exercise-Induced Anaphylaxis

Anaphylaxis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01326741
• Other study ID #: 2010P002042
• Status: Recruiting
• Phase: N/A
• First received: March 29, 2011
• Last updated: March 30, 2011
• Start date: March 2011

Study information

• Verified date: March 2011
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Anaphylaxis
• Mastocytosis

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & 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. Epub 2007 Jul 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No