Development of a Severity Assessment Score for Nasosinus Polyposis (PSI Score)

NCT05056714 | Completed

• 1 other identifier: PSI
• Study Type: observational
• Target: 569
• Locations: 1 country
• Sites: 8

Brief Summary

nasosinus polyposis (=PNS) is a chronic inflammatory disease of the nasal cavity and sinus cavity with a prevalence of 2 to 4% in the general population. The functional impact of PNS has a major impact on one's quality of life.Medical treatment, nasal irrigations and local glucocorticoids as well as short treatment of oral glucocorticoids have shown a short-term benefit versus placebo. Surgery improves the efficacy of local treatments, but 40% of patients have a recurrence of polyps at 18 months and 20% of patients require a surgery recovery at 5 years. The development of monoclonal antibodies directly targeting the inflammatory way is a real public health issue. Bachert C. et al recently demonstrated the efficacy of Dupilumab (anti-IL-4/13 antibody) injected subcutaneously on the overall symptomatology of PNS. The marketing authorization (AMM) for the first biotherapy to be available soon includes PNS's severe nature and resistance to treatment, although there is no consensus definition or score to characterize this severity. This study aims at developping a score for assessing severity in PNS. We suggest that this assessment strategy could be applied to the PNS. The originality and the innovative character of this project is the statistical modeling behind the creation of the score. Thus, the importance of symptoms, anatomical and biological factors, the estimation of the quality of life of the patients, the level of care use and the number of surgeries all become measurable indicators that are a direct reflexion of the severity and the control of PNS, called latent variables because they cannot be directly measured. To consider this detail, modeling using structural equations seems optimal to develop a severity score (PSI score) of PNS in order to personalize the therapeutic care of patients. Main Objective: To develop a severity score for PNS using latent variable modeling: Polyps Severity Index (PSI)

Conditions

Nasal Polyposis

Outcome Measures

Primary Outcomes (1)

• Develop a severity score for PNS using latent variable modeling: Polyps Severity Index (PSI)

  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

Study Arms (1)

patients with Nasosinus Polyposis

patients with Nasosinus Polyposis included in the study

Other: Questionaries

Interventions

Questionaries OTHER

The patient will answer several questionaries

patients with Nasosinus Polyposis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with nasosinisal polyposis identified or followed up

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (8)

Centre Hospitalier Intercommunal de Créteil

Créteil, 94000, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

Hôpital kremlin Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

CHU Liile

Lille, 59000, France

Location

Hôpital de la Croix Rousse

Lyon, 69004, France

Location

CHU Lyon Sud

Lyon, 69310, France

Location

Hôpitaux Universitaires de Marseille Conception

Marseille, 13005, France

Location

Hôpital Lariboisiere

Paris, 75010, France

Location

MeSH Terms

Conditions

Nasal Polyps

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 24, 2021
• Study Start: January 27, 2022
• Primary Completion: November 24, 2024
• Study Completion: November 24, 2024
• Last Updated: February 3, 2025

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)