Anatomo-clinico-biological Profiles in Severe Nasal Polyps
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: identification anatomo-clinico-biological profiles.
- Who it may be relevant to
- Registry conditions: NASAL POLYPS. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other identification anatomo-clinico-biological profiles
to determine an anatomo-clinico-biological correlation associating the anatomopathological profile, the clinical characteristics and the cytokine signature
Primary outcome measures
- Identify anatomical profiles present in nasal sinus polyposis resistant to medical treatment. [Time frame: 1 day]
- Evaluation of symptoms related to nasal sinus polyposis by visual analogue scale [Time frame: 1 day]
- Evaluation to quality of life by Sino-Nasal Outcome Test [Time frame: 1 day]
- Identify biological profiles for patients with nasal sinus polyposis [Time frame: 1 day]
- Evaluation to cytokine concentration in serum for patients with nasal sinus polyposis [Time frame: 1 day]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- Chu Poitiers — Poitiers
Identifiers
NCT: NCT06362122 · PREDICTO-POLYP