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

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

NCT ID: NCT06065007

Condition: Mastocytosis, Systemic

Conditions: Official terms:
Mastocytosis
Mastocytosis, Systemic

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Cross-Sectional

Intervention:

Intervention type: Other
Intervention name: No intervention
Description: 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
Arm group label: Swedish cohort of persons with Systemic Mastocytosis

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.

Criteria for eligibility:

Study pop:
All patients diagnosed with Systemic Masocytosis and meets the eligibility criteria, who are registered at one of the two existing mastocytosis centres in Sweden (Uppsala or Stockholm), or can be identified through a regional representative, will be asked to participate

Sampling method: Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Karolinska Institutet

Address:
City: Stockholm
Country: Sweden

Status: Recruiting

Contact:
Last name: Johanna Ungerstedt, MD, PhD

Phone: +46733221833
Email: johanna.ungerstedt@ki.se

Facility:
Name: Uppsala University

Address:
City: Uppsala
Country: Sweden

Status: Recruiting

Contact:
Last name: Mariann Hedström, PhD

Phone: +46 18 471 3538
Email: mariann.hedstrom@pubcare.uu.se

Contact backup:
Last name: Kerstin Hamberg Levedahl, PhD student

Phone: +46 73 8665952
Email: kerstin.hamberg.levedahl@pubcare.uu.se

Start date: March 25, 2024

Completion date: November 15, 2028

Lead sponsor:
Agency: Uppsala University
Agency class: Other

Collaborator:
Agency: Karolinska Institutet
Agency class: Other

Source: Uppsala University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06065007