NCT05983003CompletedNot Applicable
Research on Identifying and Treatment Prognosis of Chronic Rhinosinusitis Based on Image and Sequencing Data
Zheng Liu1 site in 1 country3,500 target enrollmentStarted: March 1, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 3,500
- Locations
- 1
- Primary Endpoint
- Change from baseline at months 12 in visual analogue scale (VAS) after surgical intervention
Study Overview
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:
- Investigating heterogeneity.
- Developing an intelligent assessment model.
- Creating a visual tool for diagnosis and prognosis.
Detailed Description
- 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.
- 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.
- 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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 16 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •oral glucocorticoid, and intranasal steroid spray and steroid irrigation treatment were discontinued at least 3 months and 1 month before surgery, respectively;
- •without acute asthma episode or acute upper airway infection within 1 month before surgery;
- •not under allergen immunotherapy or biologic treatment.
Exclusion Criteria
- •fungal sinusitis;
- •antrochoanal polyps;
- •cystic fibrosis, vasculitis, primary ciliary dyskinesia, or immunodeficiency;
- •odontogenic maxillary sinusitis;
- •patients with history of craniocerebral trauma or sinonasal tumours.
- •insufficient CT quality (e.g., metal artifacts, motion artifacts, and lack of intact CT scan of sinuses);
- •slice thickness more than 2.5 mm.
- •women must not be pregnant, or breast-feeding;
- •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;
- •patients with emotional or mental problems are excluded;
- •patients unsuitable for inclusion based on judgement of researchers are excluded;
Outcomes
Primary Outcomes
Change from baseline at months 12 in visual analogue scale (VAS) after surgical intervention
Time Frame: 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 Outcomes
- Change from baseline at months 1, 3, 6 and 12 in nasal endoscopic score after surgical intervention(1month, 3month, 6month, 12month)
- Symptom duration(1month, 3month, 6month, 12month)
- 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)
- Revision surgery rate(12month)
- Postoperative medication(1month, 3month, 6month, 12month)
Investigators
Zheng Liu
Professor of Otolaryngology-Head & Neck Surgery Vice Director Department of ENT Tongji Hospital Tongji Medical College Huazhong University of Science and Technology Affiliation: Huazhong University of Science and Technology
Huazhong University of Science and Technology
Study Sites (1)
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