Anatomo-clinico-biological Profiles in Severe Nasal Polyps

Poitiers University Hospital

Status: Enrolling

Conditions: NASAL POLYPS

Treatments: Other: identification anatomo-clinico-biological profiles

Study type: Interventional

Funder types: Other

Identifiers

NCT06362122

PREDICTO-POLYP

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

patients with nasal polyps

Experimental group

Treatment:

Other: identification anatomo-clinico-biological profiles