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RecruitingNCT06362122Updated Jun 10, 2024

Anatomo-clinico-biological Profiles in Severe Nasal Polyps

An interventional study of identification anatomo-clinico-biological profiles in NASAL POLYPS, sponsored by Poitiers University Hospital. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-10.

Sponsored by Poitiers University Hospital · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • NASAL POLYPS
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Current or past biotherapy treatment
  • Taking general corticosteroid therapy within 4 weeks of surgery
  • Protected person
  • Pregnant women or lactating women
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    patients with nasal polyps

    Other: identification anatomo-clinico-biological profiles

Interventions

  • Otheridentification anatomo-clinico-biological profiles

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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

  2. 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)

    Time frame: 1 day

  3. 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).

    Time frame: 1 day

  4. Identify biological profiles for patients with nasal sinus polyposis

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

    Time frame: 1 day

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

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

    Time frame: 1 day

06

Study locations

1 of 1 sites recruiting
  • Chu Poitiers
    Poitiers, France
    • Florent CARSUZAA · Contact
    Recruiting
07

Registry details

Key details

Study ID
NCT06362122
Lead sponsor
Poitiers University Hospital
Responsible party
Sponsor
First posted
Apr 12, 2024
Start date
Jun 3, 2024
Primary completion
May 3, 2026 (estimated)
Completion
Oct 3, 2026 (estimated)
Last update
Jun 10, 2024

Study contacts

Florent Carsuzza, Dr
Contact
Florent.CARSUZAA@chu-poitiers.fr
+33.5.49.44.43.28
karine Garnier
Contact

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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