ClinicalTrials.gg
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

Where this study stands

Counted across the records on this site · 2026-11-13

Among 33 studies in Mastocytosis, Systemic with a site in United States — 7 open to participants now, 10 under way, 1 of them phase 3. Mastocytosis, Systemic · United States.

Started
2026
with 1 other
Observational
9 of 33
3 open now
Registered
33rd of 33
by date
Lead sponsor
2 of 33
Mayo Clinic

Among the 33 studies in Mastocytosis, Systemic with a site in United States, this one is one of 2 that started in 2026, is one of 9 observational ones, and was the 33rd registered.

Mastocytosis, Systemic

56 studies on the registry are indexed under Mastocytosis, Systemic; 16 are open to participants now.

Browse Mastocytosis, Systemic studies →

Open to participants now

7 of the 33 studies in Mastocytosis, Systemic with a site in United States are open now. Recruiting first, the newest first:

1 more — sign in →

All 7 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 14 Mastocytosis, Systemic studies recruiting now, 12 (86%) set no upper age limit and 2 (14%) stop at 75 or younger; 4 take children under 18; 1 takes healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

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.

03

Conditions studied

  • Systemic Mastocytosis

Browse trials for

04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

05

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.

06

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Aug 2027, 11 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2026
First posted
Aug 11, 2026
StartEst.
Sep 9, 2026
Primary completionEst.
Aug 31, 2027
CompletionEst.
Aug 31, 2027
Last update
Aug 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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