NASAL POLYPSNCT06362122
Anatomo-clinico-biological Profiles in Severe Nasal Polyps
A study testing identification anatomo-clinico-biological profiles in people with NASAL POLYPS, run by Poitiers University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NASAL POLYPS
- What is being tested?
- identification anatomo-clinico-biological profiles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2024to 3 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current or past biotherapy treatment
- Taking general corticosteroid therapy within 4 weeks of surgery
- Protected person
- Pregnant women or lactating women
Trial locations and contacts
1 site in 1 country.
karine Garnier contact
About this study
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.
- Conditions
- NASAL POLYPS
- Being tested
- identification anatomo-clinico-biological profiles
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
identification anatomo-clinico-biological profilesOther
to determine an anatomo-clinico-biological correlation associating the anatomopathological profile, the clinical characteristics and the cytokine signature
| Study group | Role | What they receive |
|---|---|---|
| patients with nasal polyps | Experimental | Not described Receives: Other: identification anatomo-clinico-biological profiles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
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)
Measured: 1 day
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).
Measured: 1 day
Identify biological profiles for patients with nasal sinus polyposis
The measurement to cytokine expression of naso-sinus polyps (RNA sequencing analysis)
Measured: 1 day
Evaluation to cytokine concentration in serum for patients with nasal sinus polyposis
The measurement to cytokine concentration in serum (mg/l)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start3 Jun 2024
- Primary completion3 May 2026 (estimated)
- Study completion3 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASAL POLYPSStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362122
- Sponsor's protocol ID
- PREDICTO-POLYP
- Status last verified
- May 2024
- First submitted
- 5 Feb 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomo-clinico-biological Profiles in Severe Nasal Polyps
- ClinicalTrials.gov ID
- NCT06362122
- Acronym / sponsor ID
- PREDICTO-POLYP
- Conditions
- NASAL POLYPS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 3 May 2026 (estimated)
- Study completion
- 3 Oct 2026 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with nasal polyps | Experimental | Other: identification anatomo-clinico-biological profiles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Current or past biotherapy treatment
- Taking general corticosteroid therapy within 4 weeks of surgery
- Protected person
- Pregnant women or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| identification anatomo-clinico-biological profilesto determine an anatomo-clinico-biological correlation associating the anatomopathological profile, the clinical characteristics and the cytokine signature | Other | patients with nasal polyps |
Primary outcome
Identify anatomical profiles present in nasal sinus polyposis resistant to medical treatment.
Time frame: 1 day
Caracterization 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 scale
Time frame: 1 day
the measurement by the visual analogue scale (ranging from 0 (no) to 10 (very intense)
Evaluation to quality of life by Sino-Nasal Outcome Test
Time frame: 1 day
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).
Identify biological profiles for patients with nasal sinus polyposis
Time frame: 1 day
The measurement to cytokine expression of naso-sinus polyps (RNA sequencing analysis)
Evaluation to cytokine concentration in serum for patients with nasal sinus polyposis
Time frame: 1 day
The measurement to cytokine concentration in serum (mg/l)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
Related trials for NASAL POLYPS
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Nasal Polyps
RecruitingPhase 3
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
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Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
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Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
karine Garnier contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing identification anatomo-clinico-biological profiles in people with NASAL POLYPS, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florent Carsuzza, Dr (+33.5.49.44.43.28, Florent.CARSUZAA@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify anatomical profiles present in nasal sinus polyposis resistant to medical treatment. (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.