A Study Of Indolent Systemic Mastocytosis (PRISM)
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
- Rochester, Minnesota: 25-006166
NCT ID: NCT07757893
Sponsor Protocol Number: 25-006166
About this study
The purpose of this study is to identify -omics signature profiles correlating with and predictive of SM symptomatology and to evaluate -omics signature profiles of differing SM therapies, along with comparing -omics signature profiles with currently used urinary studies of mast cell mediators.
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 indolent systemic mastocytosis as defined by the World Health Organization 2022 criteria.
Adults ≥ 18 years of age or older.
Doses of baseline treatment medications are stable for ≥ 14 days prior to enrollment.
Patient must have an Eastern Cooperative Oncology Group Performance Status of 0 to 2.
Exclusion Criteria:
Age <18 years old.
Diagnosis of advanced systemic mastocytosis defined by established criteria as outlined by the World Health Organization 2022 criteria.
Patient must not have had any cytoreductive therapy including but not limited to cladribine, interferon alpha, pegylated interferon, or antibody therapy < 28 days prior to enrollment.
Any other significant medical issue as determined by the principal investigator.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 04/20/2026. 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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Thanai Pongdee, M.D. |
Contact us for the latest status |
|
More information
Publications
Publications are currently not available