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

Zheng Liu

Status: Completed

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

Treatments: Procedure: endoscopic sinus surgery

Study type: Observational

Funder types: Other

Identifiers

NCT05983003

ENT-Radiology-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,500 patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

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;

Trial design

3,500 participants in 2 patient groups

Control

Description:

Following the efficacy assessment method outlined in the 2020 EPOS guidelines, the treatment outcomes of chronic sinusitis are categorized as "controlled" or "uncontrolled." Clinical reference evaluation criteria include: nasal congestion, rhinorrhea, facial pain, reduced sense of smell, sleep disturbances, the need for ongoing medication maintenance and the abnormal nasal endoscopy findings, .If there are no three or more symptoms rated five or higher, the patient's chronic sinusitis is considered controlled.

Treatment:

Procedure: endoscopic sinus surgery

Uncontrol

Description:

Following the efficacy assessment method outlined in the 2020 EPOS guidelines, the treatment outcomes of chronic sinusitis are categorized as "controlled" or "uncontrolled." Clinical reference evaluation criteria include: nasal congestion, rhinorrhea, facial pain, reduced sense of smell, sleep disturbances, the need for ongoing medication maintenance and the abnormal nasal endoscopy findings, . The classification is based on the number and severity of these symptoms,and patients with three or more symptoms rated five or higher are considered to have uncontrolled disease

Treatment:

Procedure: endoscopic sinus surgery