(PROSPECTOR) Screening Study Evaluating the Prevalence of the KIT D816V Mutation in Patients With Systemic Mast Cell Activation

Completed

Conditions studied: Systemic Mast Cell Activation, KIT D816V Mutation

In brief

This is a multi-center screening study with the primary objective to determine the prevalence of KIT D816V mutation in peripheral blood in patients with evidence of systemic mast cell activation (MCA).

Key facts

Study ID

NCT04811365

Run by

Blueprint Medicines Corporation

People needed

379

Starts

2021-06-29

Expected to finish

2023-03-31

Last updated by the study team

2023-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Presenting with at least one of the three criteria below as evidence of systemic mast cell activation:
• 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.
• Severe anaphylaxis (Ring and Messmer grading ≥II) due to Hymenoptera sting, regardless of serum basal tryptase levels.
• 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.

You may not qualify if…

• Patient previously diagnosed with any of the following WHO systemic mastocytosis (SM) sub-classifications: mastocytosis in the skin, indolent SM, smoldering SM, SM with associated hematological neoplasm, aggressive SM, mast cell leukemia, mast cell sarcoma

Where it is running

• 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

Full record on ClinicalTrials.gov

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