Anatomo-clinico-biological Profiles in Severe Nasal Polyps

P

Poitiers University Hospital

Status

Not yet 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)

200 participants in 1 patient group

patients with nasal polyps
Experimental group
Treatment:
Other: identification anatomo-clinico-biological profiles

Trial contacts and locations

0

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Central trial contact

karine Garnier; Florent Carsuzza, Dr

Data sourced from clinicaltrials.gov

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