Anatomo-clinico-biological Profiles in Severe Nasal Polyps
ConditionNASAL POLYPS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPoitiers University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Current or past biotherapy treatment
Taking general corticosteroid therapy within 4 weeks of surgery
Protected person
Pregnant women or lactating women
Trial design
Design model
Single group
Treatments tested in this trial
identification anatomo-clinico-biological profiles
Other interventionto determine an anatomo-clinico-biological correlation associating the anatomopathological profile, the clinical characteristics and the cytokine signature
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: patients with nasal polypsExperimental treatment 1 intervention
Trial outcomes
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 day2
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 day3
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 day4
Identify biological profiles for patients with nasal sinus polyposis
The measurement to cytokine expression of naso-sinus polyps (RNA sequencing analysis)
Time frame
1 daySponsors and contacts
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Source ClinicalTrials.gov