Anatomo-clinico-biological Profiles in Severe Nasal Polyps

NCT06362122 | Recruiting

• 1 other identifier: PREDICTO-POLYP
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

NASAL POLYPS

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

patients with nasal polyps

EXPERIMENTAL

Other: identification anatomo-clinico-biological profiles

Interventions

identification anatomo-clinico-biological profiles OTHER

to determine an anatomo-clinico-biological correlation associating the anatomopathological profile, the clinical characteristics and the cytokine signature

patients with nasal polyps

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

Chu Poitiers

Poitiers, France

RECRUITING

MeSH Terms

Conditions

Nasal Polyps

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Florent Carsuzza, Dr

CONTACT

+33.5.49.44.43.28; Florent.CARSUZAA@chu-poitiers.fr

karine Garnier

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: April 12, 2024
• Study Start: June 3, 2024
• Primary Completion: May 3, 2026
• Study Completion (Estimated): October 3, 2026
• Last Updated: June 10, 2024

Record last verified: 2024-05

Locations

FR (1)