Mastocytosis, SystemicNCT06065007
Quality of Life and Disease-related Symptoms in Individuals With Systemic Mastocytosis
An observational study of Mastocytosis, Systemic, run by Uppsala University at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mastocytosis, Systemic
- How many people
- 400 participants
- Where
- 2 sitesSweden
- Study dates
- 25 Mar 2024to 15 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
About this study
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.
Read the 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
- Being tested
- No intervention
- Medical subject headings
- Mastocytosis, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
EORTC QLQ C-30
EORTC QLQ C-30 measures health related quality of life rated by individuals with malignancies and the general population. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems
Measured: Day 1
The Mastocytosis Quality of Life Questionnaire (MC-QoL)
The Mastocytosis Quality of Life Questionnaire (MC-QoL), measures disease-specific quality of life items, has scores from 0 to 100, where higher scores indicate higher health-related quality-of-life impairment
Measured: Day 1
The Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS), 14 items, is a screening tool for anxiety and depression in non-psychiatric clinical populations. There are 7 items for depression and 7 items for anxiety. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. A higher score indicates a higher level of distress.
Measured: Day 1
The Gastrointestinal Symptom Rating Scale (GSRS)
The Gastrointestinal Symptom Rating Scale (GSRS), 15 items. This instrument measures The Gastrointestinal Symptom Rating Scale (GSRS). This instrument measures gastrointestinal symptoms in individuals with irritable bowel syndrome, gastric or duodenal ulcers and dyspepsia. The questionnaire, which contains 15 items, 6 subscales with total score between 19 to 133. Higher scores indicates more symptoms.
Measured: Day 1
The Visceral Sensitivity Index (VSI)
The Visceral Sensitivity Index (VSI), 15 items, measures psychosocial consequences and worries of gastrointestinal symptoms. Each item scores 0-6 and a higher score indicates greater GI symptom-specific anxiety.
Measured: Day 1
The Brief Pain Inventory - Short form (BPI-SF)
The Brief Pain Inventory - Short form (BPI-SF), 9 items, yields a rating of levels of pain during a 24-hour period, and a description of the nature of that pain. The instrument also contains items on the impact (if any) of the pain of daily life. Each rating scale is bounded by the words "no pain" at the 0 end and "pain as bad as you can imagine" at the other. Using similar scales of 0 to 10, patients are also asked to rate the extent to which their pain interferes with 7 quality-of-life domains that include general activity, walking, mood, sleep, work, relations with other persons, and enjoyment of life. These scales are bounded by the words "does not interfere" and "interferes completely: Higher scores indicates higher levels of pain/Higher impact of pain on daily life.
Measured: day 1
The Brunnsviken Brief Quality of life scale (BBQ)
The Brunnsviken Brief Quality of life scale (BBQ), 12 items, has 4-graded response alternatives. The scale measures the overall self-experienced quality of life. The Satisfaction and Importance rating for each life area is multiplied and summed for a total quality of life score ((items 1 * 2) + (items 3 * 4) and so forth). Higher scores indicate higher levels of subjective QoL.
Measured: Day 1
Self Care of Chronic Illness Inventory
Self Care of Chronic Illness Inventory, 29 items, measures self-care behaviors in persons with chronic illnesses. The scale measures three aspects of self care; Self-Care Maintenance, Self-Care Monitoring (or Symptom Perception), and Self-Care Management. Scores on each scale are standardized to range from 0 to100 with higher scores indicating better self-care
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start25 Mar 2024
- Primary completion30 Sep 2024
- Study completion15 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Mastocytosis, SystemicStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Mariann Hedström, PhD, Principal investigator, Uppsala University, Department of Public Health and Caring Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065007
- Sponsor's protocol ID
- SMQoL230918
- Status last verified
- Apr 2025
- First submitted
- 26 Sep 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27089859Brockow 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.
PubMed 18186813Fuchs 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.
PubMed 33346151Gulen 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.
PubMed 26347286Hermans 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.
PubMed 26809706Jennings 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.
PubMed 24565772Jennings 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.
PubMed 35777651Levedahl 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.
PubMed 35963124Pardanani 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.
PubMed 33524167Pulfer 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.
PubMed 33965596Siebenhaar 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.
PubMed 26797792Spolak-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.
PubMed 36090735Ungerstedt 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.
PubMed 36010937Hamberg Levedahl K, Carlson M, Nilsson GP, Jakobsson Larsson B, Ahsberg E, Hedstrom M. Investigating instruments for evaluation of gastrointestinal burdens in patients with systemic mastocytosis: an exploratory multimethod study. Scand J Gastroenterol. 2026 Feb;61(2):160-169. doi: 10.1080/00365521.2025.2604778. Epub 2025 Dec 21.
PubMed 41424055
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Disease-related Symptoms in Individuals With Systemic Mastocytosis
- ClinicalTrials.gov ID
- NCT06065007
- Acronym / sponsor ID
- SMQoL230918
- Conditions
- Mastocytosis, Systemic
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 15 Nov 2028 (estimated)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Swedish cohort of persons with Systemic Mastocytosis | – | Other: No interventionWe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is a cross-sectional observational study, no intervention will be implemented or exposure studied. Data for outcomes of interest will be collected via questionnaires | Other | Swedish cohort of persons with Systemic Mastocytosis |
Primary outcome
EORTC QLQ C-30
Time frame: Day 1
EORTC QLQ C-30 measures health related quality of life rated by individuals with malignancies and the general population. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems
The Mastocytosis Quality of Life Questionnaire (MC-QoL)
Time frame: Day 1
The Mastocytosis Quality of Life Questionnaire (MC-QoL), measures disease-specific quality of life items, has scores from 0 to 100, where higher scores indicate higher health-related quality-of-life impairment
The Hospital Anxiety and Depression Scale (HADS)
Time frame: Day 1
The Hospital Anxiety and Depression Scale (HADS), 14 items, is a screening tool for anxiety and depression in non-psychiatric clinical populations. There are 7 items for depression and 7 items for anxiety. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. A higher score indicates a higher level of distress.
The Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Day 1
The Gastrointestinal Symptom Rating Scale (GSRS), 15 items. This instrument measures The Gastrointestinal Symptom Rating Scale (GSRS). This instrument measures gastrointestinal symptoms in individuals with irritable bowel syndrome, gastric or duodenal ulcers and dyspepsia. The questionnaire, which contains 15 items, 6 subscales with total score between 19 to 133. Higher scores indicates more symptoms.
The Visceral Sensitivity Index (VSI)
Time frame: Day 1
The Visceral Sensitivity Index (VSI), 15 items, measures psychosocial consequences and worries of gastrointestinal symptoms. Each item scores 0-6 and a higher score indicates greater GI symptom-specific anxiety.
The Brief Pain Inventory - Short form (BPI-SF)
Time frame: day 1
The Brief Pain Inventory - Short form (BPI-SF), 9 items, yields a rating of levels of pain during a 24-hour period, and a description of the nature of that pain. The instrument also contains items on the impact (if any) of the pain of daily life. Each rating scale is bounded by the words "no pain" at the 0 end and "pain as bad as you can imagine" at the other. Using similar scales of 0 to 10, patients are also asked to rate the extent to which their pain interferes with 7 quality-of-life domains that include general activity, walking, mood, sleep, work, relations with other persons, and enjoyment of life. These scales are bounded by the words "does not interfere" and "interferes completely: Higher scores indicates higher levels of pain/Higher impact of pain on daily life.
The Brunnsviken Brief Quality of life scale (BBQ)
Time frame: Day 1
The Brunnsviken Brief Quality of life scale (BBQ), 12 items, has 4-graded response alternatives. The scale measures the overall self-experienced quality of life. The Satisfaction and Importance rating for each life area is multiplied and summed for a total quality of life score ((items 1 * 2) + (items 3 * 4) and so forth). Higher scores indicate higher levels of subjective QoL.
Self Care of Chronic Illness Inventory
Time frame: Day 1
Self Care of Chronic Illness Inventory, 29 items, measures self-care behaviors in persons with chronic illnesses. The scale measures three aspects of self care; Self-Care Maintenance, Self-Care Monitoring (or Symptom Perception), and Self-Care Management. Scores on each scale are standardized to range from 0 to100 with higher scores indicating better self-care
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Background: PubMed 27089859van 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.
- Background: PubMed 18186813Brockow 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.
- Background: PubMed 33346151Fuchs 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.
- Background: PubMed 26347286Gulen 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.
- Background: PubMed 26809706Hermans 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.
- Background: PubMed 24565772Jennings 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.
- Background: PubMed 35777651Jennings 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.
- Background: PubMed 35963124Levedahl 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.
- Background: PubMed 33524167Pardanani 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.
- Background: PubMed 33965596Pulfer 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.
- Background: PubMed 26797792Siebenhaar 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.
- Background: PubMed 36090735Spolak-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariann Hedström, PhD principal investigator
Uppsala University, Department of Public Health and Caring Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mastocytosis, Systemic, run by Uppsala University at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EORTC QLQ C-30 (time frame: Day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06065007, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.