Precision Medicine for Indolent Systemic Mastocytosis (PRISM)
PRISM
1 other identifier
observational
25
1 country
1
Brief Summary
This study is being done to better understand how symptoms of Systemic Mastocytosis (SM) relate to biological signals and to better understand how different treatments affect these signals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2026
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2026
CompletedFirst Posted
Study publicly available on registry
August 11, 2026
CompletedStudy Start
First participant enrolled
September 9, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
Study Completion
Last participant's last visit for all outcomes
August 31, 2027
August 11, 2026
August 1, 2026
12 months
August 6, 2026
August 6, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Participant Completion Rate at 12 Weeks
Proportion of enrolled participants who remain in the study and complete the 12 weeks of sample and data collection.
12 weeks
Study Arms (1)
Indolent Systemic Mastocytosis Cohort
Adults aged 18 years and older with a diagnosis of indolent systemic mastocytosis who meet eligibility criteria will complete prospective symptom, ePRO/QoL, wearable, environmental exposure, and biospecimen collection over the study period.
Eligibility Criteria
Participants will be identified from Mayo Clinic and Mayo Clinic Health System clinical populations, including individuals actively followed for systemic mastocytosis, and may be approached during routine clinical visits, through electronic health record review, by telephone, text message, EHR portal message, or through participant-initiated contact via the study website.
You may qualify if:
- Diagnosis of indolent systemic mastocytosis as defined by the World Health Organization 2022 criteria.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Biospecimen
Blood and urine specimens will be collected approximately five times, once every two weeks, during the study period. Specimens will undergo proteomic and metabolomic analyses, and blood and urine samples may be stored for future research as described in the protocol.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thanai Pongdee, MD
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 6, 2026
First Posted
August 11, 2026
Study Start (Estimated)
September 9, 2026
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
August 11, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share