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

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.

Study Overview

• Status: Recruiting
• Conditions: Progression; Chronic Sinusitis; Surgery; Radiology; Pathology
• Intervention / Treatment: Procedure: endoscopic sinus surgery

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 Type: Observational
• Enrollment (Estimated): 3500

Contacts and Locations

• Study Contact: Name: Zheng Liu, doctor; Phone Number: 86 027 83663807; Email: zhengliuent@hotmail.com
• Study Contact Backup: Name: Ming Zeng, Doctor; Phone Number: 86 027 83663681; Email: zmsx77@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Zheng Liu, doctor; Phone Number: 86 027 83663807; Email: zhengliuent@hotmail.com
      • Principal Investigator: Zheng Liu, doctor
      • Principal Investigator: Heng Wang, doctor
      • Contact: Wang, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Chronic rhinosinusitis (CRS) was diagnosed according to the international guideline European position paper on rhinosinusitis and nasal polyps (EPOS) 2020. All the patients had ongoing symptoms after initial attempts on medical treatments and underwent endoscopic sinus surgery.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; 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.	Procedure: endoscopic sinus surgery; Open the sinus ostium, improve anatomical issues and remove the diseased tissue.; Other Names: ESS
Uncontrol; 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	Procedure: endoscopic sinus surgery; Open the sinus ostium, improve anatomical issues and remove the diseased tissue.; Other Names: ESS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Revision surgery rate	The rate of reoperation in each group after surgery	12month
Symptom duration	The time of duration of major symptoms of postoperative patients	1month, 3month, 6month, 12month
Postoperative medication	The duration and dose of postoperative medication needed to relieve symptoms	1month, 3month, 6month, 12month
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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-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.	1month, 3month, 6month, 12month
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

Collaborators and Investigators

• Sponsor: Zheng Liu
• Investigators: Principal Investigator: Zheng Liu, Doctor, Huazhong University of Science and Techology

Publications and helpful links

General Publications

• 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, Diamant Z, Douglas RG, Gevaert PH, Hafner A, Harvey RJ, Joos GF, Kalogjera L, Knill A, Kocks JH, Landis BN, Limpens J, Lebeer S, Lourenco O, Meco C, Matricardi PM, O'Mahony L, Philpott CM, Ryan D, Schlosser R, Senior B, Smith TL, Teeling T, Tomazic PV, Wang DY, Wang D, Zhang L, Agius AM, Ahlstrom-Emanuelsson C, Alabri R, Albu S, Alhabash S, Aleksic A, Aloulah M, Al-Qudah M, Alsaleh S, Baban MA, Baudoin T, Balvers T, Battaglia P, Bedoya JD, Beule A, Bofares KM, Braverman I, Brozek-Madry E, Richard B, Callejas C, Carrie S, Caulley L, Chussi D, de Corso E, Coste A, El Hadi U, Elfarouk A, Eloy PH, Farrokhi S, Felisati G, Ferrari MD, Fishchuk R, Grayson W, Goncalves PM, Grdinic B, Grgic V, Hamizan AW, Heinichen JV, Husain S, Ping TI, Ivaska J, Jakimovska F, Jovancevic L, Kakande E, Kamel R, Karpischenko S, Kariyawasam HH, Kawauchi H, Kjeldsen A, Klimek L, Krzeski A, Kopacheva Barsova G, Kim SW, Lal D, Letort JJ, Lopatin A, Mahdjoubi A, Mesbahi A, Netkovski J, Nyenbue Tshipukane D, Obando-Valverde A, Okano M, Onerci M, Ong YK, Orlandi R, Otori N, Ouennoughy K, Ozkan M, Peric A, Plzak J, Prokopakis E, Prepageran N, Psaltis A, Pugin B, Raftopulos M, Rombaux P, Riechelmann H, Sahtout S, Sarafoleanu CC, Searyoh K, Rhee CS, Shi J, Shkoukani M, Shukuryan AK, Sicak M, Smyth D, Sindvongs K, Soklic Kosak T, Stjarne P, Sutikno B, Steinsvag S, Tantilipikorn P, Thanaviratananich S, Tran T, Urbancic J, Valiulius A, Vasquez de Aparicio C, Vicheva D, Virkkula PM, Vicente G, Voegels R, Wagenmann MM, Wardani RS, Welge-Lussen A, Witterick I, Wright E, Zabolotniy D, Zsolt B, Zwetsloot CP. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020 Feb 20;58(Suppl S29):1-464. doi: 10.4193/Rhin20.600.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: July 30, 2023
• First Submitted That Met QC Criteria: August 8, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Progression; Chronic Sinusitis; Radiology
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Disease Progression; Sinusitis
• Other Study ID Numbers: ENT-Radiology-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No