Characterisation of Nasal Polyps in Patients With and Without Aspirin-exacerbated Respiratory Dis… (NCT03848156) | Clinical Trial Compass
CompletedNot Applicable
Characterisation of Nasal Polyps in Patients With and Without Aspirin-exacerbated Respiratory Disease
Austria23 participantsStarted 2019-02-12
Plain-language summary
Prevalence of aspirin-exacerbated respiratory disease (AERD) is 16% amongst patients suffering from chronic rhinosinusitis with nasal polyps (CRSwNP). The mechanisms underlying the observed dysregulation of pro and anti-inflammatory pathways in AERD are still not fully understood. To address this and also to identify potential factors characterizing the disease the investigators plan to prospectively collect blood samples, nasal secretions as well as nasal biopsies from allergic, non-allergic and AERD patients suffering from CRSwNP. Initially, polyps of aforementioned patients will be subjected to RNA sequencing analysis using microarray technology. Once distinct factors are identified in nasal polyp tissue, their presence will be assessed in nasal secretions and serum of the respective patients to investigate their potential role as biomarkers. Furthermore presence of these parameters will be confirmed in situ in biopsies by confocal microscopy. Knowledge about factors differently upregulated in polyp tissue from AERD may contribute to a better understanding of the underlying mechanism of the disease.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Male or Female
* Age: 18-90
* Willingness to participate in the study
* Suffering from CRSwNP (with or without prior history of surgery for nasal polyposis)
* Allergic or non-allergic: if no recent allergy test is available (max. two years old) the presence or absence of allergy will be determined by skin prick test and by ImmunoCAP for allergen-specific serum immunoglobulin E (IgE) levels in addition to assessment of patients's history by questionnaire.
* Suffering from AERD or not as confirmed by provocation testing
Exclusion criteria:
* Children
* Pregnant women - the presence of a known pregnancy will be assessed during the visit by questionnaire
* A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
RNA Sequencing of polyps using Illumina platform
Timeframe: patients will be recruited over the course of one year until 20 patients have been reached. Each patient will be sequenced when the sample is received.