NCT06065007

Quality of Life and Disease-related Symptoms in Individuals With Systemic Mastocytosis

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Systemic Mastocytosis is a rare and complex disease caused by accumulation of mast cells. The skin, bones, gastrointestinal tract, bone marrow and liver are the organs most often affected. Symptoms can vary greatly between patients. The study aims to describe the Swedish cohort's self-rated quality of life and levels of disease-related symptoms.

Detailed description

Systemic Mastocytosis (SM) is a rare and complex disease caused by accumulation of mast cells leading to release of mediator substances (e.g., cytokines, prostaglandins, histamine and tryptase). The skin, bones, gastrointestinal tract, bone marrow and liver are the organs most often affected. Symptoms vary between patients and can include e.g., allergic reactions with anaphylaxis, rashes, osteoporoses, cognitive difficulties, fatigue, depression, anxiety, nausea, vomiting, stomach pains and diarrhea. In this cross-sectional observational study, the aim is to include the Swedish cohort of persons diagnosed with SM to gather a wide range of information on self-rated health-related quality of life, gastrointestinal symptoms, pain, anxiety, depression and self-care.

Conditions

• Mastocytosis, Systemic

Interventions

Type	Name	Description
OTHER	No intervention	This is a cross-sectional observational study, no intervention will be implemented or exposure studied. Data for outcomes of interest will be collected via questionnaires

Timeline

• Start date: 2024-03-25
• Primary completion: 2024-09-30
• Completion: 2028-11-15
• First posted: 2023-10-03
• Last updated: 2025-04-04

Locations

2 sites across 1 country: Sweden