Research on Identifying and Treatment Prognosis of Chronic Rhinosinusitis Based on Image and Sequencing Data

Completed

• Conditions: Surgery; Radiology; Progression; Chronic Sinusitis; Pathology

• Registration Number: NCT05983003
• Lead Sponsor: Zheng Liu

Brief Summary

This project focuses on researching chronic rhinosinusitis in patients, employing image processing techniques and molecular biology methods to jointly determine the research objectives:

1. Investigating heterogeneity.

2. Developing an intelligent assessment model.

3. Creating a visual tool for diagnosis and prognosis.

Detailed Description

1. Investigating the heterogeneity of chronic rhinosinusitis: the project will utilize high-throughput information from various sources such as radiology, pathology, and proteomics to gain insights into the multi-dimensional and big data aspects of chronic rhinosinusitis. By analyzing this data, the study aims to identify and understand the different subtypes with more precise and personalized treatment approaches.

2. Developing an intelligent assessment model: using artificial intelligence algorithms, the project will analyze multi-omics data gathered from the research. The goal is to establish an intelligent assessment model that can accurately interpret the data and provide valuable insights into chronic rhinosinusitis.

3. Creating a visual tool for diagnosis and prognosis: the project seeks to integrate multi-omics information to establish an AI model for typing and prognostic prediction. By achieving these research objectives, this project aspires to enhance the understanding of chronic rhinosinusitis and contribute to the development of more precise, personalized, and effective treatment strategies for patients suffering from this condition.

Study Timeline

• Study Start: 2015-03-01
• Study First Submitted: 2023-07-30
• Study First Submitted QC: 2023-08-08
• Study First Posted: 2023-08-09
• Primary Completion: 2024-04
• Study Completion: 2024-04-01
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-20
• Last Update Posted: 2025-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3500

Inclusion Criteria

1. oral glucocorticoid, and intranasal steroid spray and steroid irrigation treatment were discontinued at least 3 months and 1 month before surgery, respectively;
2. without acute asthma episode or acute upper airway infection within 1 month before surgery;
3. not under allergen immunotherapy or biologic treatment.

Exclusion Criteria

1. fungal sinusitis;
2. antrochoanal polyps;
3. cystic fibrosis, vasculitis, primary ciliary dyskinesia, or immunodeficiency;
4. odontogenic maxillary sinusitis;
5. patients with history of craniocerebral trauma or sinonasal tumours.
6. insufficient CT quality (e.g., metal artifacts, motion artifacts, and lack of intact CT scan of sinuses);
7. slice thickness more than 2.5 mm.
8. women must not be pregnant, or breast-feeding;
9. patients with serious metabolic, cardiovascular, autoimmune, neurology, blood, digestive, cerebrovascular, or respiratory system disease, or any disease interfering with the evaluation of results or affecting subjects safety are excluded, such as glaucoma and tuberculosis;
10. patients with emotional or mental problems are excluded;
11. patients unsuitable for inclusion based on judgement of researchers are excluded;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline at months 12 in visual analogue scale (VAS) after surgical intervention	12month	The VAS for rhinosinusitis was used to evaluate the total disease severity. The participants were asked to indicate on a 10 centimeters (cm) VAS the answer to the question, "How troublesome are your symptoms of your rhinosinusitis?" The range of the VAS was from 0 (not troublesome) to 10 (worse thinkable troublesome) of troublesome, where higher score indicated worse thinkable troublesome.

Secondary Outcome Measures

Name	Time	Method
Change from baseline at months 1, 3, 6 and 12 in nasal endoscopic score after surgical intervention	1month, 3month, 6month, 12month	Endoscopic result is scored according to Lund-Kennedy system, with the assessment of nasal polyp (NP), edema, nasal discharge, scarring and crusting. Items including edema, nasal discharge, scarring and crusting score 0 for no problem, 1 for mild abnormalities and 2 for severe abnormalities. NP score is graded and based on NP size recorded as the sum of the right and left nostril scores with a range of 0-8; higher scores indicate worse status. Individual score ranges from 0 (no polyps) to 4 (large polyps causing almost complete congestion/ obstruction of the inferior meatus) within each nostril.
Symptom duration	1month, 3month, 6month, 12month	The time of duration of major symptoms of postoperative patients
Change from baseline at months 1, 3, 6 and 12 in 22-item sino-nasaloutcome test (SNOT-22) scores after surgical intervention	1month, 3month, 6month, 12month	The SNOT-22 is a validated questionnaire that was used to assess the impact of chronic rhinosinusitis on health-related quality of life (HRQoL). It is a 22 item questionnaire with each item assigned a score ranging from 0 (no problem) to 5 (problem as bad as it can be). The total score may range from 0 (no disease) to 110 (worst disease), lower scores representing better health related quality of life.
Revision surgery rate	12month	The rate of reoperation in each group after surgery
Postoperative medication	1month, 3month, 6month, 12month	The duration and dose of postoperative medication needed to relieve symptoms

Trial Locations

Locations (1)

Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China