xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05983003</url>
    </required_header>
    <id_info>
      <org_study_id>ENT-Radiology-01</org_study_id>
      <nct_id>NCT05983003</nct_id>
    </id_info>
    <brief_title>Research on Identifying and Treatment Prognosis of Chronic Rhinosinusitis Based on Image and Sequencing Data</brief_title>
    <official_title>Research on Identifying and Treatment Prognosis of Chronic Rhinosinusitis Based on Image and Sequencing Data</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zheng Liu</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Huazhong University of Science and Technology</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This project focuses on researching chronic rhinosinusitis in patients, employing image&#xD;
        processing techniques and molecular biology methods to jointly determine the research&#xD;
        objectives:&#xD;
  &#xD;
          1. Investigating heterogeneity.&#xD;
  &#xD;
          2. Developing an intelligent assessment model.&#xD;
  &#xD;
          3. Creating a visual tool for diagnosis and prognosis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        1. Investigating the heterogeneity of chronic rhinosinusitis: the project will utilize&#xD;
             high-throughput information from various sources such as radiology, pathology, and&#xD;
             proteomics to gain insights into the multi-dimensional and big data aspects of chronic&#xD;
             rhinosinusitis. By analyzing this data, the study aims to identify and understand the&#xD;
             different subtypes with more precise and personalized treatment approaches.&#xD;
  &#xD;
          2. Developing an intelligent assessment model: using artificial intelligence algorithms,&#xD;
             the project will analyze multi-omics data gathered from the research. The goal is to&#xD;
             establish an intelligent assessment model that can accurately interpret the data and&#xD;
             provide valuable insights into chronic rhinosinusitis.&#xD;
  &#xD;
          3. Creating a visual tool for diagnosis and prognosis: the project seeks to integrate&#xD;
             multi-omics information to establish an AI model for typing and prognostic prediction.&#xD;
             By achieving these research objectives, this project aspires to enhance the&#xD;
             understanding of chronic rhinosinusitis and contribute to the development of more&#xD;
             precise, personalized, and effective treatment strategies for patients suffering from&#xD;
             this condition.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 2015</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline at months 12 in visual analogue scale (VAS) after surgical intervention</measure>
      <time_frame>12month</time_frame>
      <description>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, &quot;How troublesome are your symptoms of your rhinosinusitis?&quot; The range of the VAS was from 0 (not troublesome) to 10 (worse thinkable troublesome) of troublesome, where higher score indicated worse thinkable troublesome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from baseline at months 1, 3, 6 and 12 in 22-item sino-nasaloutcome test (SNOT-22) scores after surgical intervention</measure>
      <time_frame>1month, 3month, 6month, 12month</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Revision surgery rate</measure>
      <time_frame>12month</time_frame>
      <description>The rate of reoperation in each group after surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Symptom duration</measure>
      <time_frame>1month, 3month, 6month, 12month</time_frame>
      <description>The time of duration of major symptoms of postoperative patients</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline at months 1, 3, 6 and 12 in nasal endoscopic score after surgical intervention</measure>
      <time_frame>1month, 3month, 6month, 12month</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative medication</measure>
      <time_frame>1month, 3month, 6month, 12month</time_frame>
      <description>The duration and dose of postoperative medication needed to relieve symptoms</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Changes from baseline at months 1, 3, 6 and 12 in molecular indices of nasal lavage fluid by Bio-plex</measure>
      <time_frame>1month, 3month, 6month, 12month</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes from baseline at months 1, 3, 6 and 12 in molecular indices of nasal lavage fluid by ELISA</measure>
      <time_frame>1month, 3month, 6month, 12month</time_frame>
      <description>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.</description>
    </other_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">3500</enrollment>
    <condition>Chronic Sinusitis</condition>
    <condition>Radiology</condition>
    <condition>Pathology</condition>
    <condition>Surgery</condition>
    <condition>Progression</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <description>Following the efficacy assessment method outlined in the 2020 EPOS guidelines, the treatment outcomes of chronic sinusitis are categorized as &quot;controlled&quot; or &quot;uncontrolled.&quot; 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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Uncontrol</arm_group_label>
      <description>Following the efficacy assessment method outlined in the 2020 EPOS guidelines, the treatment outcomes of chronic sinusitis are categorized as &quot;controlled&quot; or &quot;uncontrolled.&quot; 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</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>endoscopic sinus surgery</intervention_name>
      <description>Open the sinus ostium, improve anatomical issues and remove the diseased tissue.</description>
      <arm_group_label>Control</arm_group_label>
      <arm_group_label>Uncontrol</arm_group_label>
      <other_name>ESS</other_name>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        For patients with chronic sinusitis undergoing surgical treatment, nasal polyps or ethmoid&#xD;
        sinus lesion mucosa will be collected during the operation. For the control group, mucosa&#xD;
        will be taken from patients undergoing surgery for nasal septum deviation or nasal sinus&#xD;
        trauma, and normal ethmoid sinus mucosa or inferior turbinate tissue will be collected during&#xD;
        the operation. The collected tissue specimens will be divided into two parts, with one part&#xD;
        being fixed in 4% paraformaldehyde and the other part stored at -80°C.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Chronic rhinosinusitis (CRS) was diagnosed according to the international guideline&#xD;
          European position paper on rhinosinusitis and nasal polyps (EPOS) 2020. All the patients&#xD;
          had ongoing symptoms after initial attempts on medical treatments and underwent endoscopic&#xD;
          sinus surgery.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. oral glucocorticoid, and intranasal steroid spray and steroid irrigation treatment&#xD;
               were discontinued at least 3 months and 1 month before surgery, respectively;&#xD;
  &#xD;
            2. without acute asthma episode or acute upper airway infection within 1 month before&#xD;
               surgery;&#xD;
  &#xD;
            3. not under allergen immunotherapy or biologic treatment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. fungal sinusitis;&#xD;
  &#xD;
            2. antrochoanal polyps;&#xD;
  &#xD;
            3. cystic fibrosis, vasculitis, primary ciliary dyskinesia, or immunodeficiency;&#xD;
  &#xD;
            4. odontogenic maxillary sinusitis;&#xD;
  &#xD;
            5. patients with history of craniocerebral trauma or sinonasal tumours.&#xD;
  &#xD;
            6. insufficient CT quality (e.g., metal artifacts, motion artifacts, and lack of intact&#xD;
               CT scan of sinuses);&#xD;
  &#xD;
            7. slice thickness more than 2.5 mm.&#xD;
  &#xD;
            8. women must not be pregnant, or breast-feeding;&#xD;
  &#xD;
            9. patients with serious metabolic, cardiovascular, autoimmune, neurology, blood,&#xD;
               digestive, cerebrovascular, or respiratory system disease, or any disease interfering&#xD;
               with the evaluation of results or affecting subjects safety are excluded, such as&#xD;
               glaucoma and tuberculosis;&#xD;
  &#xD;
           10. patients with emotional or mental problems are excluded;&#xD;
  &#xD;
           11. patients unsuitable for inclusion based on judgement of researchers are excluded;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Zheng Liu, Doctor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Huazhong University of Science and Techology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Zheng Liu, Doctor</last_name>
      <phone>86 027 83663807</phone>
      <email>zhengliuent@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ming Zeng, Doctor</last_name>
      <phone>86 027 83663681</phone>
      <email>zmsx77@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430030</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Zheng Liu, doctor</last_name>
        <phone>86 027 83663807</phone>
        <email>zhengliuent@hotmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Wang, Doctor</last_name>
      </contact_backup>
      <investigator>
        <last_name>Zheng Liu, doctor</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Heng Wang, doctor</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <results_reference>
      <citation>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.</citation>
      <PMID>32077450</PMID>
    </results_reference>
    <results_reference>
      <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.</citation>
      <PMID>22252861</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Huazhong University of Science and Technology</investigator_affiliation>
      <investigator_full_name>Zheng Liu</investigator_full_name>
      <investigator_title>Professor of Otolaryngology-Head &amp; 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</investigator_title>
    </responsible_party>
    <keyword>Chronic Sinusitis</keyword>
    <keyword>Radiology</keyword>
    <keyword>Progression</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sinusitis</mesh_term>
      <mesh_term>Disease Progression</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05983003
  org study id: ENT-Radiology-01
  nct id: NCT05983003
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  observational model: Cohort
  time perspective: Retrospective
  measure: Change from baseline at months 12 in visual analogue scale (VAS) after surgical intervention
  time frame: 12month
  description: 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.
  measure: Change from baseline at months 1, 3, 6 and 12 in 22-item sino-nasaloutcome test (SNOT-22) scores after surgical intervention
  time frame: 1month, 3month, 6month, 12month
  description: 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.
  measure: Revision surgery rate
  time frame: 12month
  description: The rate of reoperation in each group after surgery
  measure: Symptom duration
  time frame: 1month, 3month, 6month, 12month
  description: The time of duration of major symptoms of postoperative patients
  measure: Change from baseline at months 1, 3, 6 and 12 in nasal endoscopic score after surgical intervention
  time frame: 1month, 3month, 6month, 12month
  description: 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.
  measure: Postoperative medication
  time frame: 1month, 3month, 6month, 12month
  description: The duration and dose of postoperative medication needed to relieve symptoms
  measure: Changes from baseline at months 1, 3, 6 and 12 in molecular indices of nasal lavage fluid by Bio-plex
  time frame: 1month, 3month, 6month, 12month
  description: 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.
  measure: Changes from baseline at months 1, 3, 6 and 12 in molecular indices of nasal lavage fluid by ELISA
  time frame: 1month, 3month, 6month, 12month
  description: 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.
  arm group label: 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.
  arm group label: 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
  intervention type: Procedure
  intervention name: endoscopic sinus surgery
  description: Open the sinus ostium, improve anatomical issues and remove the diseased tissue.
  arm group label: Control
  arm group label: Uncontrol
  other name: ESS
  For patients with chronic sinusitis undergoing surgical treatment, nasal polyps or ethmoid
        sinus lesion mucosa will be collected during the operation. For the control group, mucosa
        will be taken from patients undergoing surgery for nasal septum deviation or nasal sinus
        trauma, and normal ethmoid sinus mucosa or inferior turbinate tissue will be collected during
        the operation. The collected tissue specimens will be divided into two parts, with one part
        being fixed in 4% paraformaldehyde and the other part stored at -80°C.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Zheng Liu, Doctor
  role: Principal Investigator
  affiliation: Huazhong University of Science and Techology
  last name: Zheng Liu, Doctor
  phone: 86 027 83663807
  email: zhengliuent@hotmail.com
  last name: Ming Zeng, Doctor
  phone: 86 027 83663681
  email: zmsx77@163.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: China
  citation: 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.
  PMID: 32077450
  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.
  PMID: 22252861
  responsible party type: Sponsor-Investigator
  investigator affiliation: Huazhong University of Science and Technology
  investigator full name: Zheng Liu
  investigator title: 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
  mesh term: Sinusitis
  mesh term: Disease Progression
  sharing ipd: No