Boston, Massachusetts 02115


Purpose:

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.


Criteria:

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 is Available At:


Original ID:

2010P002042


NCT ID:

NCT01326741


Secondary ID:


Study Acronym:


Brief Title:

Clonal Mast Cell Disorders in Exercise-Induced Anaphylaxis


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

21 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Brigham and Women's Hospital


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: R


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

10


Enrollment Type:

Anticipated


Study Dates

Start Date:March 2011
Verification Date:March 2011
Last Changed Date:March 30, 2011
First Received Date:March 29, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Number of participants with presence of clonal abnormalities in the bone marrow specimen
Time Frame:Baseline
Safety Issues:False
Description:Presence of clonal mast cells in bone marrow as assessed by D816V c-kit mutation or CD25 will be recorded for each participant.
Outcome Type:Primary Outcome
Measure:Number of participants with presence of clonal abnormalities in the bone marrow specimen
Time Frame:Baseline
Safety Issues:False
Description: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 th

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Brigham and Women's Hospital

Samples and Retentions

Study Population: Ten adults of either sex
Sample Method:Non-Probability Sample

Study References

Reference Type:Reference
Citation: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.
PMID:17638853

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


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