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Clonal Mast Cell Disorders in Exercise-Induced Anaphylaxis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Brigham and Women's Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01326741
First Posted: March 31, 2011
Last Update Posted: March 31, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Brigham and Women's Hospital
  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.

Condition
Anaphylaxis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Detection of Clonal Mast Cell Disorders Among Patients With Exercise-induced Anaphylaxis

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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.

  • 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.


Estimated Enrollment: 10
Study Start Date: March 2011
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Ten adults of either sex
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01326741


Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Cem Akin, MD, PhD    617-732-9227    afeldweg@partners.org   
Contact: Anna M Feldweg, MD    617 869 2031    afeldweg@partners.org   
Principal Investigator: Cem Akin, MD, PhD         
Sub-Investigator: Anna M Feldweg, MD         
Sub-Investigator: Albert L Sheffer, MD         
Sub-Investigator: Mariana Castells, MD, PhD         
Sub-Investigator: Mary Hogan, RN         
Sponsors and Collaborators
Brigham and Women's Hospital
  More Information

Publications:
Responsible Party: Cem Akin, MD, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01326741     History of Changes
Other Study ID Numbers: 2010P002042
First Submitted: March 29, 2011
First Posted: March 31, 2011
Last Update Posted: March 31, 2011
Last Verified: March 2011

Keywords provided by Brigham and Women's Hospital:
clonal mast cell disorder
exercise-induced anaphylaxis
hypotension

Additional relevant MeSH terms:
Anaphylaxis
Mastocytosis
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Skin Diseases