- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05056714
Development of a Severity Assessment Score for Nasosinus Polyposis (PSI Score) (PSI)
Study Overview
Detailed Description
In practice, during their otolaryngologist (ORL) consultation, patients will have a complete clinical check-up and will be prescribed the necessary complementary examinations if they have not already been performed recently (<6 months). All data will be collected in an anonymous database.
The patient will answer a questionnaire to evaluate the cardinal symptoms of PNS using a visual scale from 0 to 10. He will then have a standard ORL clinical check-up (otoscopy, then rhinoscopy with speculum and nasal endoscopy) in order to make a nasal anatomical assessment (duration 5 minutes).
They will be given a questionnaire on admission to the waiting room to find out the impact of their nasal discomfort on their quality of life (score used routinely and validated in the literature, SNOT-22), as well as a questionnaire concerning their asthma if it exists (score used routinely and validated in the literature, ACT). The importance of the endoscopic involvement will be evaluated using the Lidholt score (see Appendix) and the importance of the radiological involvement directly from the CT or Cone beam computed tomography (=CBCT) results using the Lund-MacKay score. The estimated time to complete these questionnaires and to assess the endoscopic and radiological involvement is an additional 10 minutes. Blood will be drawn (as part of the initial routine workup) to assess complete blood count (for blood hypereosinophilia) and IgE levels (serum and total IgE). We will repeat the assessment routinely performed as part of the follow-up of patients with PNS by questionnaire, interview and physical check-up at 3 months when the patients return for their follow-up visit. No additional exams or questionnaires to the routine workup will be performed for this study.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
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Créteil, France, 94010
- Recruiting
- Hôpital Henri Mondor
-
Créteil, France, 94000
- Recruiting
- Centre Hospitalier Intercommunal de Créteil
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Le Kremlin-Bicêtre, France, 94270
- Recruiting
- Hopital Kremlin Bicetre
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Lille, France, 59000
- Recruiting
- CHU Liile
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Lyon, France, 69004
- Recruiting
- Hôpital de La Croix Rousse
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Lyon, France, 69310
- Recruiting
- CHU Lyon Sud
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Marseille, France, 13005
- Recruiting
- Hôpitaux Universitaires de Marseille Conception
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Paris, France, 75010
- Recruiting
- Hôpital Lariboisière
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- >18 years
- Patients included are all adult (>18 years) patients with PNS: Inflammation of the nose and sinuses that is characterised by two or more of the following symptoms (at least one of which must be nasal obstruction or runny nose):
- Nasal obstruction and nasal congestion
- Rhinorrhoea (anterior or posterior)
- Facial pain or pressure
- Decreased or loss of sense of smell
- Sneezing and/or nasal pruritus
These symptoms should be associated with :
- Endoscopic signs of nasal polyps
- Diffuse bilateral naso-sinusal opacities on CT or CBCT
Exclusion Criteria:
- Decline to participate in the study
- No one who speaks or understands French
- History of skull base surgery for tumours
- History of major head trauma
- History of cerebral-facial radiotherapy or chemotherapy
- History of inflammatory or neurodegenerative neurological pathology
- Systemic disease associated with the presence of sinus polyps (Granulomatosis - with polyangiitis, cystic fibrosis, primary ciliary dyskinesia, immune deficiency)
- Cancer or haematological disease in progress
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patients with Nasosinus Polyposis
patients with Nasosinus Polyposis included in the study
|
The patient will answer several questionaries
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Develop a severity score for PNS using latent variable modeling: Polyps Severity Index (PSI)
Time Frame: 3 months
|
the estimated value of the structural coefficients relating measurable indicators of PNS to the endogenous latent variable: the severity of the disease (PSI score).
|
3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Respiratory Tract Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Colonic Diseases
- Intestinal Diseases
- Pathological Conditions, Anatomical
- Intestinal Neoplasms
- Rectal Diseases
- Nose Diseases
- Polyps
- Nasopharyngeal Neoplasms
- Colorectal Neoplasms
- Nasal Polyps
Other Study ID Numbers
- PSI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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