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Anatomo-clinico-biological Profiles in Severe Nasal Polyps

Anatomo-clinico-biological Profiles in Severe Nasal Polyps

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06362122
Enrollment
200
Registered
2024-04-12
Start date
2024-06-03
Completion date
2026-10-03
Last updated
2024-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NASAL POLYPS

Brief 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.

Interventions

OTHERidentification anatomo-clinico-biological profiles

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

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
Identify anatomical profiles present in nasal sinus polyposis resistant to medical treatment.1 dayCaracterization the profiles of patients by the presence or not of edematous or fibrous component, infiltration and lymphoplasmocytic infiltrates.
Evaluation of symptoms related to nasal sinus polyposis by visual analogue scale1 daythe measurement by the visual analogue scale (ranging from 0 (no) to 10 (very intense)
Evaluation to quality of life by Sino-Nasal Outcome Test1 daythe 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).
Identify biological profiles for patients with nasal sinus polyposis1 dayThe measurement to cytokine expression of naso-sinus polyps (RNA sequencing analysis)
Evaluation to cytokine concentration in serum for patients with nasal sinus polyposis1 dayThe measurement to cytokine concentration in serum (mg/l)

Countries

France

Contacts

Primary ContactFlorent Carsuzza, Dr
Florent.CARSUZAA@chu-poitiers.fr+33.5.49.44.43.28
Backup Contactkarine Garnier

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026