NCT05938972 Real Life Study of Biologicals in Patients With Severe CRSwNP
| NCT ID | NCT05938972 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Ghent |
| Condition | Chronic Rhinosinusitis With Nasal Polyps |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2022-03-01 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 180 participants in total. It began in 2022-03-01 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a pragmatic, real-life, observational study recruiting adult patients with chronic rhinosinusitis with nasal polyposis who are eligible to start biologicals as standard treatment. The aim of this study is to observe the long-term outcomes of biologicals in CRSwNP patients with or without comorbid asthma in 'real life'. Moreover, the investigators will gain insight into the mechanisms of biologicals in the local and systemic immunity of these patients and investigate novel local and systemic biomarkers and predictors of response.
Eligibility Criteria
Inclusion Criteria: Patients must meet the following criteria to be eligible for the enrolment in the study: * Signed informed consent form (ICF), * Age between 18 and 80 years at time of signing ICF, * Able to comply with the study protocol, in the investigator's judgment, * In group one: patients with severe allergic and/or eosinophilic asthma, defined by being currently treated with a biological (SoC) OR starting treatment with a biological (SoC). * In group two: patients with CRSwNP with or without asthma, defined by starting treatment with a biological (SoC) and fulfill the criteria for reimbursement of a biological therapy Exclusion Criteria: Patients who do not meet the reimbursement criteria of a biological therapy cannot participate in the study.
Contact & Investigator
Philippe Gevaert, Prof. Dr.
PRINCIPAL INVESTIGATOR
University Hospital, Ghent
Frequently Asked Questions
Who can join the NCT05938972 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Chronic Rhinosinusitis With Nasal Polyps. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05938972 currently recruiting?
Yes, NCT05938972 is actively recruiting participants. Contact the research team at manon.blauwblomme@ugent.be for enrollment information.
Where is the NCT05938972 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT05938972 clinical trial?
NCT05938972 is sponsored by University Hospital, Ghent. The principal investigator is Philippe Gevaert, Prof. Dr. at University Hospital, Ghent. The trial plans to enroll 180 participants.