Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06362122

Anatomo-clinico-biological Profiles in Severe Nasal Polyps

Led by Poitiers University Hospital · Updated on 2024-06-10

200

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Nasal sinus polyposis is a chronic inflammatory condition affecting the nasal cavity and sinuses, leading to multiple bilateral polyps. This condition affects 2 to 4% of the general population and is challenging to manage because current treatments often fail or lead to symptom recurrence. Researchers are studying the anatomical, clinical, and biological profiles of patients with severe nasal polyps to better predict how patients will respond to surgery and biotherapy treatments. The study involves identifying anatomo-clinico-biological correlations by examining the anatomopathological profile, clinical features, and cytokine signatures of nasal polyps. These profiles aim to guide patient management, especially for those resistant to medical treatments and requiring first-time surgical treatment such as ethmoidectomy. The research assesses these factors to help predict treatment response, including to newer biologic therapies. Participants will undergo evaluations including anatomical profiling, symptom assessment using a visual analogue scale, quality of life measurement with the Sino-Nasal Outcome Test, biological profiling, and cytokine concentration analysis in serum. These assessments occur on a single day. The study monitors symptom severity, quality of life, and biological markers to understand treatment resistance. Participation involves a one-day visit for these detailed evaluations under medical supervision.

CONDITIONS

Brief Title

Anatomo-clinico-biological Profiles in Severe Nasal Polyps

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is 18 years or older
  • Diagnosed with nasal sinus polyposis resistant to medical treatment
  • Requiring first-time surgical treatment with ethmoidectomy
  • Has signed the consent form
  • Has health insurance coverage
Not Eligible

You will not qualify if you...

  • Current or past treatment with biotherapy
  • Use of general corticosteroid therapy within 4 weeks before surgery
  • Protected person status (legal protection)
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo first-time surgical treatment with ethmoidectomy and immediate post-operative care.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants are evaluated for anatomical and biological profiles related to nasal sinus polyposis, including symptom assessment and quality of life evaluation.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Chu Poitiers

Poitiers, France

Actively Recruiting

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Research Team

F

Florent Carsuzza, Dr

K

karine Garnier

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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