(PROSPECTOR) Screening Study Evaluating the Prevalence of the KIT D816V Mutation in Patients With Systemic Mast Cell Activation
NCT ID: NCT04811365
Last Updated: 2023-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
379 participants
OBSERVATIONAL
2021-06-29
2023-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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Screening
After providing informed consent, relevant medical history data, and blood and buccal swab samples will be collected at a single visit from patients presenting with systemic mast cell activation symptoms
Eligibility Criteria
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Inclusion Criteria
1. Involvement of 2 or more organ systems, characterized by skin (pruritus, urticaria, flushing and angioedema), cardiovascular (tachycardia, syncope, and hypotension), gastrointestinal (diarrhea, nausea, vomiting, and gastrointestinal cramping) or respiratory/naso-ocular (wheezing, conjunctival injection, and nasal stuffiness) AND serum basal tryptase levels ≥8 ng/ml. One of the organ systems must be the cardiovascular system.
2. Severe anaphylaxis (Ring and Messmer grading ≥II) due to Hymenoptera sting, regardless of serum basal tryptase levels.
3. Severe anaphylaxis (Ring and Messmer grading ≥II), with cardiovascular involvement and documented event-related tryptase elevation fitting the formula 20% of baseline plus 2 ng/ml evaluated in at least 1 event.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Blueprint Medicines Corporation
INDUSTRY
Responsible Party
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Locations
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Clinical Research Center of Alabama
Birmingham, Alabama, United States
Scripps Clinic Carmel Valley
San Diego, California, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Roswell Park Cancer Center
Buffalo, New York, United States
Albert P. Hirdt D.O. P.C.
New Paltz, New York, United States
Columbia University Medical Center - Herbert Irving Comprehensive Cancer Center HICCC
New York, New York, United States
Duke University: Duke Allergy Asthma Airway Center
Durham, North Carolina, United States
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, United States
Antwerp University Hospital UZA
Edegem, , Belgium
Pitié-Salpêtrière Hospital
Paris, , France
CHU Toulouse
Toulouse, , France
Charite Universitatsmedizin Berlin
Berlin, , Germany
Medizinische Hochschule Hannover, Dept. of Dermatology and Allergy
Hanover, , Germany
Klinik fuer Dermatologie und Allergologie
München, , Germany
AOU San Giovanni di Dio e Ruggi d'Aragona University of Salerno
Salerno, , Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, , Italy
Hospital Virgen del Valle
Toledo, , Spain
University of Basel
Basel, , Switzerland
University Hospital of Leicester
Leicester, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, , United Kingdom
Countries
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Other Identifiers
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BLU-SM-1101
Identifier Type: -
Identifier Source: org_study_id
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