Development of A Multi-section Olfactory Cleft Opacity Staging System in Patients With CCAD

NCT07380945 | Not Yet Recruiting DMC

• 1 other identifier: 9059105
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop a modified CT scoring system to evaluate the association between olfactory cleft obstruction patterns and olfactory dysfunction in patients with central region atopic disease (CCAD). The main questions that the clinical trial aims to answer are: Can this modified CT scoring system be used to assess the degree of olfactory impairment in patients with CCAD? How well does the modified CT score correlate with the patient's olfaction compared to the traditional CT score?

Conditions

Central Compartment Atopic Disease (CCAD)

Keywords

olfactory cleft; olfactory dysfuction

Outcome Measures

Primary Outcomes (2)

• Evaluation of the novel olfactory cleft CT scoring system for imaging assessment in CCAD patients

  Validation of the novel CT scoring system for superior characterization of olfactory cleft obstruction compared to the traditional CT scoring system.

  Immediately after CT scans

• Predictive performance of the novel olfactory cleft CT scoring system

  Construct a predictive model for CCAD using logistic regression, incorporating both the novel CT score and peripheral blood eosinophil percentage, and compare it with the traditional olfactory cleft CT scoring system.

  Immediately after CT scans

Secondary Outcomes (2)

• Correlation between novel olfactory cleft CT scores in different regions and CCAD diagnosis

  Immediately after CT scans

• Association between the novel olfactory cleft CT score, olfactory function, and eosinophil percentage

  Immediately after CT scans

Study Arms (2)

Patients with CCAD

Other: Computer Tomography

non-CCAD patients with chronic rhinosinusitis

Other: Computer Tomography

Interventions

Computer Tomography OTHER

low-dose CT is taken

Also known as: collection of the percentage of peripheral blood eosinophils

Patients with CCAD; non-CCAD patients with chronic rhinosinusitis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients were recruited from the Department of Otolaryngology at Peking University Third Hospital in clinic.

You may qualify if:

• Diagnosed with CCAD based on the diagnostic criteria of the EPOS guideline.
• Provision of signed and dated informed consent form.
• Diagnosed with CRS (non-CCAD) based on the diagnostic criteria of the EPOS guideline.
• Provision of signed and dated informed consent form.

You may not qualify if:

• Those who have taken oral glucocorticoids, antibiotics, anti-leukotrienes, and antihistamines within four weeks.
• Patients who have had prior sinus surgery.
• Patients with fungal sinusitis, inverted papilloma, or other nasal diseases.
• Patients with a diagnosis of immune suppression or suspicion of malignancy that may be affecting the nose/paranasal sinuses.
• Patients who are mentally or physically unable to perform olfactory tests

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Department of Otolaryngology Head and Neck Surgery, Peking University Third Hospital

Beijing, People's Republic of China, 10019, China

Location

Central Study Contacts

Dawei Wu, MD, PhD

CONTACT

+86-10-13522503401; davidwuorl@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Researcher

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: February 2, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)