ClinicalTrials.gg
Status unknownNCT06376071Updated Apr 19, 2024

Sinonasal Risk Factors for Occurrence of Unilateral Versus Bilateral Allergic Fungal Rhinosinusitis .

An observational study in Allergic Fungal Rhinosinusitis, sponsored by Assiut University. Status unknown. Per ClinicalTrials.gov, last updated 2024-04-19.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-crossover
Time perspective
Cross-sectional
Enrollment
76
Sex
All
01

Study summary

This study aims to assess Sinonasal risk factors for occurrence of unilateral versus bilateral allergic fungal rhino sinusitis regarding::

  1. anatomical variations and correlate radiological finding with intraoperative finding.
  2. other associated factors like demographic ,environmental, immunological and climatic risk factors .
Read the detailed description

Introduction Allergic fungal rhinosinusitis (AFRS) is a subtype of CRS with nasal polyposis (CRSwNP) that is characterized by eosinophilic mucin within expanded sinus cavities and immunoglobulin E (IgE)-mediated type 1 hypersensitivity to fungal elements. This noninvasive disease process typically affects immunocompetent, younger patients in geographic regions with warm temperatures and high humidity, which facilitate fungal proliferation.

AFRS has a worldwide distribution pattern with varying prevalence. AFRS is presented in variable rates in different climatic, socioeconomic, and geographic factors. The disease prevalence showed predilection toward climatic factors

02

Conditions studied

  • Allergic Fungal Rhinosinusitis
03

In context

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients will be divided into two groups:

Group (A): including patients with unilateral allergic fungal rhinosinusitis. Group (B): including patients with bilateral allergic fungal rhinosinusitis. Then all patient will subjected to EFSS under general anathesia with wide sinusotomics where intraoperative collection of data will be done as the follow

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Denovo cases . any Age Any sex. Patients diagnosed with unilateral or bilateral allergic fungal rhino sinusitis, meeting classic Bent and Kuhn criteria for AFRS:(10).

Nasal polyposis. Fungi on staining. Eosinophilic mucin without fungal invasion into sinus tissue., Type I hypersensitivity to fungi. Characteristic radiologic findings with soft-tissue differential densities on computed tomographic (CT) scanning

Exclusion criteria

Exclusion criteria:

Diagnosis of benign or malignant neoplasm of the sinonasal cavity. Prior radiation therapy to the head or neck. Significant prior facial trauma. Autoimmune disorder. Craniofacial anomaly. Fungus ball. Immunodeficiency. Cystic fibrosis. Patients unfit for surgery. Previous nasal surgery or recurrent cases .

05

Study design

Observational model
Case-crossover
Time perspective
Cross-sectional
Enrollment
76 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testfunctional endoscopic sinus surgery

    functional endoscopic sinus surgery for diagnosis the disease

06

What researchers measure

Primary outcomes

  1. Sinonasal risk factors for occurrence of unilateral versus bilateral allergic fungal rhinosinusitis

    analysis of the risk factors of unilateral versus bilateral allergic fungal rhinosinusitis

    Time frame: baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Kwon E, Sutton AE, O'Rourke MC. Chronic Sinusitis. 2026 Jan 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441934/ PubMed 28722963 ↗
  • Akhondi H, Sutton AE, Rajasurya V. Fungal Sinusitis. 2026 May 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK551496/ PubMed 31855340 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2024; primary completion for May 2025, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 17, 2024
First posted
Apr 19, 2024
StartEst.
May 1, 2024
Primary completionEst.
May 1, 2025
CompletionEst.
Jun 30, 2025
Last update
Apr 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06376071
Lead sponsor
Assiut University
Responsible party
Al khater nosir sayed (Sinonasal risk factors for occurrence of unilateral versus bilateral allergic fungal rhinosinusitis, Assiut University) — Principal investigator
First posted
Apr 19, 2024
Start date
May 1, 2024 (estimated)
Primary completion
May 1, 2025 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Apr 19, 2024

Study contacts

khater nosir sayed, master
Contact
khatrsnyr289@gmail.com
01011973180

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion