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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06362122
Other study ID # PREDICTO-POLYP
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 3, 2024
Est. completion date October 3, 2026

Study information

Verified date May 2024
Source Poitiers University Hospital
Contact Florent Carsuzza, Dr
Phone +33.5.49.44.43.28
Email Florent.CARSUZAA@chu-poitiers.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date October 3, 2026
Est. primary completion date May 3, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Chu Poitiers Poitiers

Sponsors (1)

Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 day
Primary 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) 1 day
Primary 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). 1 day
Primary Identify biological profiles for patients with nasal sinus polyposis The measurement to cytokine expression of naso-sinus polyps (RNA sequencing analysis) 1 day
Primary Evaluation to cytokine concentration in serum for patients with nasal sinus polyposis The measurement to cytokine concentration in serum (mg/l) 1 day
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