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

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ClinicalTrials.gov Identifier: NCT05056714
Recruitment Status : Not yet recruiting
First Posted : September 24, 2021
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

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)

Condition or disease Intervention/treatment
Nasal Polyposis Other: Questionaries

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 550 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Development of a Severity Assessment Score for Nasosinus Polyposis (PSI Score)
Estimated Study Start Date : October 1, 2021
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : December 31, 2023

Group/Cohort Intervention/treatment
patients with Nasosinus Polyposis
patients with Nasosinus Polyposis included in the study
Other: Questionaries
The patient will answer several questionaries




Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with nasosinisal polyposis identified or followed up
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05056714


Contacts
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Contact: Emilie BEQUIGNON 01 49 81 22 25 ext +33 Emilie.bequignon@chicreteil.fr
Contact: Camille JUNG 01 45 17 50 00 ext +33 camille.jung@chicreteil.fr

Locations
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France
Centre Hospitalier Intercommunal de Créteil
Créteil, France, 94000
Contact: André COSTE    01 57 02 29 47 ext +33    andre.coste@chicreteil.fr   
Hôpital Henri Mondor
Créteil, France, 94010
Contact: Sophie BARTIER         
Hôpital kremlin Bicêtre
Le Kremlin-Bicêtre, France, 94270
Contact: Jean François PAPON         
CHU Liile
Lille, France, 59000
Contact: Geoffrey MORTUAIRE         
Hôpital de la Croix Rousse
Lyon, France, 69004
CHU Lyon Sud
Lyon, France, 69310
Contact: Maxime FIEUX         
Hôpitaux Universitaires de Marseille Conception
Marseille, France, 13005
Hôpital Lariboisiere
Paris, France, 75010
Contact: Benjamin Verillaud         
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
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Responsible Party: Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT05056714    
Other Study ID Numbers: PSI
First Posted: September 24, 2021    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Nasopharyngeal Neoplasms
Nasal Polyps
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Nose Diseases
Respiratory Tract Diseases
Polyps
Pathological Conditions, Anatomical