Quality of Life and Disease-related Symptoms in Individuals With Systemic Mastocytosis
NCT ID: NCT06065007
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
400 participants
OBSERVATIONAL
2024-03-25
2028-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Swedish cohort of persons with Systemic Mastocytosis
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* The patient has undergone an allogeneic stem cell transplant
18 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Uppsala University
OTHER
Responsible Party
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Principal Investigators
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Mariann Hedström, PhD
Role: PRINCIPAL_INVESTIGATOR
Uppsala University, Department of Public Health and Caring Sciences
Locations
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Karolinska Institutet
Stockholm, , Sweden
Uppsala University
Uppsala, , Sweden
Countries
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References
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van Anrooij B, Kluin-Nelemans JC, Safy M, Flokstra-de Blok BM, Oude Elberink JN. Patient-reported disease-specific quality-of-life and symptom severity in systemic mastocytosis. Allergy. 2016 Nov;71(11):1585-1593. doi: 10.1111/all.12920. Epub 2016 Jun 23.
Brockow K, Jofer C, Behrendt H, Ring J. Anaphylaxis in patients with mastocytosis: a study on history, clinical features and risk factors in 120 patients. Allergy. 2008 Feb;63(2):226-32. doi: 10.1111/j.1398-9995.2007.01569.x.
Fuchs D, Kilbertus A, Kofler K, von Bubnoff N, Shoumariyeh K, Zanotti R, Bonadonna P, Scaffidi L, Doubek M, Elberink HO, Span LFR, Hermine O, Elena C, Benvenuti P, Yavuz AS, Brockow K, Zink A, Aberer E, Gorska A, Romantowski J, Hadzijusufovic E, Fortina AB, Caroppo F, Perkins C, Illerhaus A, Panse J, Vucinic V, Jawhar M, Sabato V, Triggiani M, Parente R, Bergstrom A, Breynaert C, Gotlib J, Reiter A, Hartmann K, Niedoszytko M, Arock M, Kluin-Nelemans HC, Sperr WR, Greul R, Valent P. Scoring the Risk of Having Systemic Mastocytosis in Adult Patients with Mastocytosis in the Skin. J Allergy Clin Immunol Pract. 2021 Apr;9(4):1705-1712.e4. doi: 10.1016/j.jaip.2020.12.022. Epub 2020 Dec 23.
Gulen T, Hagglund H, Dahlen B, Nilsson G. Mastocytosis: the puzzling clinical spectrum and challenging diagnostic aspects of an enigmatic disease. J Intern Med. 2016 Mar;279(3):211-28. doi: 10.1111/joim.12410. Epub 2015 Sep 8.
Hermans MAW, Rietveld MJA, van Laar JAM, Dalm VASH, Verburg M, Pasmans SGMA, Gerth van Wijk R, van Hagen PM, van Daele PLA. Systemic mastocytosis: A cohort study on clinical characteristics of 136 patients in a large tertiary centre. Eur J Intern Med. 2016 May;30:25-30. doi: 10.1016/j.ejim.2016.01.005. Epub 2016 Jan 23.
Jennings S, Russell N, Jennings B, Slee V, Sterling L, Castells M, Valent P, Akin C. The Mastocytosis Society survey on mast cell disorders: patient experiences and perceptions. J Allergy Clin Immunol Pract. 2014 Jan-Feb;2(1):70-6. doi: 10.1016/j.jaip.2013.09.004. Epub 2013 Dec 3.
Jennings SV, Finnerty CC, Hobart JS, Martin-Martinez M, Sinclair KA, Slee VM, Agopian J, Akin C, Alvarez-Twose I, Bonadonna P, Bowman AS, Brockow K, Bumbea H, de Haro C, Fok JS, Hartmann K, Hegmann N, Hermine O, Kalisiak M, Katelaris CH, Kurz J, Marcis P, Mayne D, Mendoza D, Moussy A, Mudretzkyj G, Vaia NN, Niedoszytko M, Elberink HO, Orfao A, Radia DH, Rosenmeier S, Ribada E, Schinhofen W, Schwaab J, Siebenhaar F, Triggiani M, Tripodo G, Velazquez R, Wielink Y, Wimazal F, Yigit T, Zubrinich C, Valent P. Mast Cell Diseases in Practice and Research: Issues and Perspectives Raised by Patients and Their Recommendations to the Scientific Community and Beyond. J Allergy Clin Immunol Pract. 2022 Aug;10(8):2039-2051. doi: 10.1016/j.jaip.2022.06.018. Epub 2022 Jun 28.
Levedahl KH, Nilsson A, Ungerstedt J, Hedstrom M. Living with systemic mastocytosis: Balancing between vulnerability and resilience: A qualitative study. Eur J Oncol Nurs. 2022 Oct;60:102172. doi: 10.1016/j.ejon.2022.102172. Epub 2022 Jul 6.
Pardanani A. Systemic mastocytosis in adults: 2021 Update on diagnosis, risk stratification and management. Am J Hematol. 2021 Apr 1;96(4):508-525. doi: 10.1002/ajh.26118. Epub 2021 Feb 21.
Pulfer S, Ziehfreund S, Gebhard J, Hindelang B, Biedermann T, Brockow K, Zink A. Health-Related Quality of Life and Influencing Factors in Adults with Nonadvanced Mastocytosis-A Cross-Sectional Study and Qualitative Approach. J Allergy Clin Immunol Pract. 2021 Aug;9(8):3166-3175.e2. doi: 10.1016/j.jaip.2021.04.059. Epub 2021 May 26.
Siebenhaar F, von Tschirnhaus E, Hartmann K, Rabenhorst A, Staubach P, Peveling-Oberhag A, Wagner N, Martus P, Carter MC, Metcalfe DD, Church MK, Maurer M, Weller K. Development and validation of the mastocytosis quality of life questionnaire: MC-QoL. Allergy. 2016 Jun;71(6):869-77. doi: 10.1111/all.12842. Epub 2016 Feb 15.
Spolak-Bobryk N, Niedoszytko M, Jassem E, Chelminska M, Lange M, Majkowicz M, Nedoszytko B, Borchet J. The role of the clinical and psychological symptoms of mastocytosis in the patient's quality of life. Postepy Dermatol Alergol. 2022 Aug;39(4):688-696. doi: 10.5114/ada.2021.108433. Epub 2021 Sep 20.
Ungerstedt J, Ljung C, Klimkowska M, Gulen T. Clinical Outcomes of Adults with Systemic Mastocytosis: A 15-Year Multidisciplinary Experience. Cancers (Basel). 2022 Aug 16;14(16):3942. doi: 10.3390/cancers14163942.
Other Identifiers
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SMQoL230918
Identifier Type: -
Identifier Source: org_study_id
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