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NCT Number: NCT06362122

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Poitiers

Poitiers, France

Location status: Recruiting

Location contact

Florent CARSUZAA

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

identification anatomo-clinico-biological profiles

Other

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

Primary outcomes

  1. Identify anatomical profiles present in nasal sinus polyposis resistant to medical treatment.

    Time frame: 1 day

    Caracterization the profiles of patients by the presence or not of edematous or fibrous component, infiltration and lymphoplasmocytic infiltrates.

  2. Evaluation of symptoms related to nasal sinus polyposis by visual analogue scale

    Time frame: 1 day

    the measurement by the visual analogue scale (ranging from 0 (no) to 10 (very intense)

  3. Evaluation to quality of life by Sino-Nasal Outcome Test

    Time frame: 1 day

    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).

  4. Identify biological profiles for patients with nasal sinus polyposis

    Time frame: 1 day

    The measurement to cytokine expression of naso-sinus polyps (RNA sequencing analysis)

  5. Evaluation to cytokine concentration in serum for patients with nasal sinus polyposis

    Time frame: 1 day

    The measurement to cytokine concentration in serum (mg/l)

Study contacts

Contact information is provided by the study sponsor or research team.

Florent Carsuzza, Dr

CONTACT

[email protected]

+33.5.49.44.43.28

karine Garnier

CONTACT

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 12, 2024
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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