Anatomo-clinico-biological Profiles in Severe Nasal Polyps

NCT ID: NCT06362122

Last Updated: 2024-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-03

Study Completion Date

2026-10-03

Brief Summary

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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.

Detailed Description

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Conditions

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NASAL POLYPS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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patients with nasal polyps

Group Type EXPERIMENTAL

identification anatomo-clinico-biological profiles

Intervention Type OTHER

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

Interventions

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identification anatomo-clinico-biological profiles

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Poitiers

Poitiers, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Florent Carsuzza, Dr

Role: CONTACT

+33.5.49.44.43.28

karine Garnier

Role: CONTACT

Facility Contacts

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Florent CARSUZAA

Role: primary

Other Identifiers

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PREDICTO-POLYP

Identifier Type: -

Identifier Source: org_study_id

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