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

Uppsala University

Status: Active, not recruiting

Conditions: Mastocytosis, Systemic

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT06065007

SMQoL230918

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Swedish-speaking individuals aged 18 years or older and diagnosed with indolent systemic mastocytosis (ISM) or advanced systemic mastocytosis (AdvSM), verified by a bone marrow biopsy

Exclusion criteria

• An assessment by the treating physician that the individual has a cognitive impairment making participation impossible
• The patient has undergone an allogeneic stem cell transplant

Trial design

400 participants in 1 patient group

Swedish cohort of persons with Systemic Mastocytosis

Description:

We aim to include all individuals with a diagnosis of SM in Sweden, by identification via either one the two centers of excellence of mastocytosis or by a regional representative for the mastocytosis group in Sweden.

Treatment:

Other: No intervention