NCT07757893尚未招募不适用
Precision Medicine for Indolent Systemic Mastocytosis (PRISM)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Participant Completion Rate at 12 Weeks
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Participant Completion Rate at 12 Weeks
时间窗: 12 weeks
Proportion of enrolled participants who remain in the study and complete the 12 weeks of sample and data collection.
次要结局
未报告次要终点
研究者
Thanai Pongdee
Principal Investigator
Mayo Clinic
研究点 (1)
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