Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362122
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-02-05
Brief Title:
Anatomo-clinico-biological Profiles in Severe Nasal Polyps
Sponsor:
Poitiers University Hospital
Organization:
Poitiers University Hospital
Study Overview
Official Title:
Anatomo-clinico-biological Profiles in Severe Nasal Polyps
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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 patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None