Systemic MastocytosisPRISMNCT07757893
Precision Medicine for Indolent Systemic Mastocytosis (PRISM)
An observational study of Systemic Mastocytosis, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Mastocytosis
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2026to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Systemic Mastocytosis
- Medical subject headings
- Mastocytosis, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start9 Sep 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic MastocytosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thanai Pongdee, Mayo Clinic
- Investigators
- Thanai Pongdee, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757893
- Sponsor's protocol ID
- 25-006166
- Acronym
- PRISM
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine for Indolent Systemic Mastocytosis (PRISM)
- ClinicalTrials.gov ID
- NCT07757893
- Acronym / sponsor ID
- PRISM / 25-006166
- Conditions
- Systemic Mastocytosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 9 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Participant Completion Rate at 12 Weeks
Time frame: 12 weeks
Proportion of enrolled participants who remain in the study and complete the 12 weeks of sample and data collection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thanai Pongdee, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Mastocytosis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurie Mulhern (507-284-8160, Mulhern.Laurie@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Completion Rate at 12 Weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.