Informations générales (source: ClinicalTrials.gov)
Development of a Severity Assessment Score for Nasosinus Polyposis (PSI Score) (PSI)
Observational [Patient Registry]
Centre Hospitalier Intercommunal Creteil (Voir sur ClinicalTrials)
janvier 2022
décembre 2023
29 juin 2024
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)
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bicêtre | Jean François PAPON | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | Sophie BARTIER | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | Benjamin Verillaud | Contact (sur clinicalTrials) | |||
| CHI DE CRETEIL | André COSTE | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Liile - 59000 - Lille - France | Geoffrey MORTUAIRE | Contact (sur clinicalTrials) | |||
| CHU Lyon Sud - 69310 - Lyon - France | Maxime FIEUX | Contact (sur clinicalTrials) | |||
| Hôpital de la Croix Rousse - 69004 - Lyon - France | Clémentine DAVEAU | Contact (sur clinicalTrials) | |||
| Hôpitaux Universitaires de Marseille Conception - 13005 - Marseille - France | Justin MICHEL | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- >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
- 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