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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05983003
• Other study ID #: ENT-Radiology-01
• Status: Recruiting
• Start date: March 2015
• Est. completion date: November 2023

Study information

• Verified date: August 2023
• Source: Huazhong University of Science and Technology
• Contact: Zheng Liu, Doctor
• Phone: 86 027 83663807
• Email: zhengliuent[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Est. completion date: November 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Chronic Sinusitis
• Disease Progression
• Pathology
• Progression
• Radiology
• Sinusitis
• Surgery

Intervention

Procedure:
• endoscopic sinus surgery
Open the sinus ostium, improve anatomical issues and remove the diseased tissue.

Locations

Country	Name	City	State
China	Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zheng Liu

Country where clinical trial is conducted

China, 

References & Publications (2)

Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S, Toppila-Salmi S, Bernal-Sprekelsen M, Mullol J, Alobid I, Terezinha Anselmo-Lima W, Bachert C, Baroody F, von Buchwald C, Cervin A, Cohen N, Constantinidis J, De Gabory L, Desrosiers M, Diama — View Citation

Hu Y, Cao PP, Liang GT, Cui YH, Liu Z. Diagnostic significance of blood eosinophil count in eosinophilic chronic rhinosinusitis with nasal polyps in Chinese adults. Laryngoscope. 2012 Mar;122(3):498-503. doi: 10.1002/lary.22507. Epub 2012 Jan 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes from baseline at months 1, 3, 6 and 12 in molecular indices of nasal lavage fluid by Bio-plex	Investigate 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-1ß, macrophage inflammatory protein-1a 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.	1month, 3month, 6month, 12month
Other	Changes from baseline at months 1, 3, 6 and 12 in molecular indices of nasal lavage fluid by ELISA	Investigate 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.	1month, 3month, 6month, 12month
Primary	Change from baseline at months 12 in visual analogue scale (VAS) after surgical intervention	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.	12month
Secondary	Change from baseline at months 1, 3, 6 and 12 in 22-item sino-nasaloutcome test (SNOT-22) scores after surgical intervention	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.	1month, 3month, 6month, 12month
Secondary	Revision surgery rate	The rate of reoperation in each group after surgery	12month
Secondary	Symptom duration	The time of duration of major symptoms of postoperative patients	1month, 3month, 6month, 12month
Secondary	Change from baseline at months 1, 3, 6 and 12 in nasal endoscopic score after surgical intervention	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.	1month, 3month, 6month, 12month
Secondary	Postoperative medication	The duration and dose of postoperative medication needed to relieve symptoms	1month, 3month, 6month, 12month