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Not yet recruitingNCT07757893PRISMUpdated Aug 18, 2026

Precision Medicine for Indolent Systemic Mastocytosis (PRISM)

An observational study in Systemic Mastocytosis, sponsored by Mayo Clinic. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Systemic Mastocytosis

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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, electronic health record (EHR) portal message, or through participant-initiated contact via the study website.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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, electronic patient reported outcomes (ePRO), quality of life (QOL) assessments, wearable, environmental exposure, and biospecimen collection over the study period.

05

What researchers measure

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.

    Time frame: 12 weeks

06

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07757893
Lead sponsor
Mayo Clinic
Responsible party
Thanai Pongdee (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Aug 11, 2026
Start date
Sep 9, 2026 (estimated)
Primary completion
Aug 31, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Aug 18, 2026

Study contacts

Laurie Mulhern
Contact
Mulhern.Laurie@mayo.edu
507-284-8160
Kay Bachman
Contact
Bachman.Kay@mayo.edu
507-284-5689
Thanai Pongdee, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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