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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05983003
Enrollment
3500
Registered
2023-08-09
Start date
2015-03-31
Completion date
2024-04-30
Last updated
2025-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Sinusitis, Pathology, Progression, Radiology, Surgery

Keywords

Chronic Sinusitis, Radiology, Progression

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.

Interventions

PROCEDUREendoscopic sinus surgery

Open the sinus ostium, improve anatomical issues and remove the diseased tissue.

Sponsors

Wuhan Central Hospital
CollaboratorOTHER
First Affiliated Hospital of Zhongshan Medical University
CollaboratorOTHER
Clifford Hospital, Guangzhou, China
CollaboratorOTHER
The First Affiliated Hospital of Zhengzhou University
CollaboratorOTHER
Shanxi Bethune Hospital
CollaboratorOTHER
The First Affiliated Hospital of Nanchang University
CollaboratorOTHER
Xiangyang Central Hospital
CollaboratorOTHER
Longgang District People's Hospital of Shenzhen
CollaboratorOTHER
Wuhan Integrated Traditional Chinese and Western Medicine Hospital
CollaboratorOTHER
Wuhan Third Hospital
CollaboratorOTHER
Yangxin Hospital
CollaboratorUNKNOWN
Zheng Liu
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline at months 12 in visual analogue scale (VAS) after surgical intervention12monthThe 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

MeasureTime frameDescription
Change from baseline at months 1, 3, 6 and 12 in 22-item sino-nasaloutcome test (SNOT-22) scores after surgical intervention1month, 3month, 6month, 12monthThe 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 rate12monthThe rate of reoperation in each group after surgery
Symptom duration1month, 3month, 6month, 12monthThe time of duration of major symptoms of postoperative patients
Change from baseline at months 1, 3, 6 and 12 in nasal endoscopic score after surgical intervention1month, 3month, 6month, 12monthEndoscopic 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.
Postoperative medication1month, 3month, 6month, 12monthThe duration and dose of postoperative medication needed to relieve symptoms

Other

MeasureTime frameDescription
Changes from baseline at months 1, 3, 6 and 12 in molecular indices of nasal lavage fluid by Bio-plex1month, 3month, 6month, 12monthInvestigate the change of inflammation molecular biomarkers using sample of nasal lavage fluid or mucosal lesion tissue. Biomarkers including interleukin 9, monocyte chemoattractant protein-1, macrophage inflammatory protein-1β, macrophage inflammatory protein-1α and chemokine (C-C motif ) ligand 17 in nasal lavage fluid by Bio-plex (Bio-Rad, Hercules, CA, USA) at months 1, 3, 6 and 12 were detected to compare the changes of molecular indices relative to baseline.
Changes from baseline at months 1, 3, 6 and 12 in molecular indices of nasal lavage fluid by ELISA1month, 3month, 6month, 12monthInvestigate the change of inflammation molecular biomarkers using sample of nasal lavage fluid or mucosal lesion tissue. Biomarkers including Immunoglobulin (Ig) E in nasal lavage fluid by enzyme linked immunosorbent assay (ELISA) at months 1, 3, 6 and 12 were detected to compare the changes of molecular indices relative to baseline.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026