Anatomo-clinico-biological Profiles in Severe Nasal Polyps

NASAL POLYPS Clinical Trial

Official title:

Anatomo-clinico-biological Profiles in Severe Nasal Polyps

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06362122
• Other study ID #: PREDICTO-POLYP
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• NASAL POLYPS
• Polyps

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