Clinical trial · Observational
Precision Medicine for Indolent Systemic Mastocytosis (PRISM)
NCT07757893CI-TRIAL-00122505PRISMnot yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Systemic Mastocytosis | Systemic Mastocytosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Indolent Systemic Mastocytosis Cohort
- description
- 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.
Primary outcomes (1)
- measure
- Participant Completion Rate at 12 Weeks
- timeFrame
- 12 weeks
- description
- Proportion of enrolled participants who remain in the study and complete the 12 weeks of sample and data collection.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.