A Study Of Urinary Mast Cell Mediators As Biomarkers Of Treatment Response In Chronic Spontaneous Urticaria
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Austin, Minnesota: 26-008260
- Owatonna, Minnesota: 26-008260
- Rochester, Minnesota: 26-008260
About this study
The purpose of this study is to evaluate the association between changes in urinary mast cell mediator levels and changes in clinical disease activity in patients with chronic spontaneous urticaria, as measured by urticaria assessment instruments (UAS-7 and UCT scores) from baseline to 8 weeks following therapy initiation.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Signed informed consent form
Diagnosis of CSU (recurrent urticaria for ≥6 weeks without identifiable trigger) under the treatment of a clinician within the Division of Allergic Diseases at Mayo Clinic in Rochester, MN or in select Allergy Clinics within Mayo Clinic Health System (MCHS) in Austin, MN or Owatonna, MN
Initiation, escalation, or modification of CSU pharmacotherapy at the enrollment visit
Age ≥ 18 years
Willing and able to provide urine samples at baseline, 4 weeks, and 8 weeks
Exclusion Criteria:
Age < 18 years old
Physical, cognitive, or language limitations that preclude reliable completion of study questionnaires (UAS-7 and UCT), as determined by the investigator
Change in medications that impact urinary mast cell mediators outside of what is prescribed by the Allergy/Immunology clinician during the study period (at the discretion of the study team)
Any condition that, in the investigator’s judgment, would interfere with study participation or interpretation of results
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 08/10/2026. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Austin, Minn.
Mayo Clinic principal investigator |
Contact us for the latest status |
|
Owatonna, Minn.
Mayo Clinic principal investigator |
Contact us for the latest status |
|
Rochester, Minn.
Mayo Clinic principal investigator |
Contact us for the latest status |
|
More information
Publications
Publications are currently not available