Anatomo-clinico-biological Profiles in Severe Nasal Polyps

Nasal sinus polyposis is a chronic inflammatory pathology of the nasal cavity and sinus cavities that causes bilateral and multifocal polyp development and has a prevalence of 2 to 4% in the general population.

Therapeutic management consists of first-line medical treatment for anti-inflammatory purposes. Local corticosteroid therapy, using nasal sprays, is the background treatment. Surgical management is offered to patients in case of failure of medical treatment. Although effective, surgery does not protect patients from recurrence of symptoms related to regrowth of polyps. Recently, biologics have appeared, which despite its effectiveness, about 20% of patients have a partial or no response to these treatments. There is currently no possibility of determining the probability of response to treatments in patients.

It is therefore essential to determine an anatomo-clinico-biological correlation associating the anatomopathological profile, the clinical characteristics and the cytokine signature in order to best guide the patient's management, including the initiation of biotherapy. Indeed, patients, according to their clinical, biological characteristics and the cytokine signature of their polyps will react differently to different treatments, including surgery and biotherapy. This correlation will serve as a predictor of treatment response.

Study Overview

• Status: Not yet recruiting
• Conditions: NASAL POLYPS
• Intervention / Treatment: Other: identification anatomo-clinico-biological profiles

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florent Carsuzza, Dr; Phone Number: +33.5.49.44.43.28; Email: Florent.CARSUZAA@chu-poitiers.fr
• Study Contact Backup: Name: karine Garnier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient ≥ 18 year-old
• Patient with nasal sinus polyposis resistant to medical treatment and requiring surgical treatment with ethmoidectomy type is considered for the first time
• Having signed the consent form
• Having an health insurance

Exclusion Criteria:

• Current or past biotherapy treatment
• Taking general corticosteroid therapy within 4 weeks of surgery
• Protected person
• Pregnant women or lactating women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients with nasal polyps	Other: identification anatomo-clinico-biological profiles; to determine an anatomo-clinico-biological correlation associating the anatomopathological profile, the clinical characteristics and the cytokine signature

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify anatomical profiles present in nasal sinus polyposis resistant to medical treatment.	Caracterization the profiles of patients by the presence or not of edematous or fibrous component, infiltration and lymphoplasmocytic infiltrates.	1 day
Evaluation of symptoms related to nasal sinus polyposis by visual analogue scale	the measurement by the visual analogue scale (ranging from 0 (no) to 10 (very intense)	1 day
Evaluation to quality of life by Sino-Nasal Outcome Test	the measurement to quality of life by Sino-Nasal Outcome Test (test SNOT-22: test is a questionnaire that reviews 22 symptoms. Each item quantifies the severity of the symptom from 0 (no problem) to 5 (very severe problem). The maximum score is 110, a high score indicating a significant impact of symptoms).	1 day
Identify biological profiles for patients with nasal sinus polyposis	The measurement to cytokine expression of naso-sinus polyps (RNA sequencing analysis)	1 day
Evaluation to cytokine concentration in serum for patients with nasal sinus polyposis	The measurement to cytokine concentration in serum (mg/l)	1 day

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Nose Diseases; Nasal Polyps; Polyps
• Other Study ID Numbers: PREDICTO-POLYP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No