<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/NCT04475952</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS 257483</org_study_id>
    <nct_id>NCT04475952</nct_id>
  </id_info>
  <brief_title>Early Diagnosis of Upper Digestive Tract Disease</brief_title>
  <acronym>E-DIGEST</acronym>
  <official_title>Early Diagnosis of Upper Digestive Tract Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imperial College London</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Upper digestive tract cancer (UDC) is a major disease burden worldwide encompassing all&#xD;
      cancers involving the digestive tract (from oral cavity to duodenum). A majority of patients&#xD;
      presenting with this disease are diagnosed late and have poor overall survival rates (&lt;20%).&#xD;
      NICE referral guidelines for diagnostic endoscopy are usually associated with late disease.&#xD;
      Exhaled breath testing is a non-invasive and acceptable technology utilising mass&#xD;
      spectrometry (MS) which has shown promise at diagnosing cancer at an early stage.&#xD;
&#xD;
      Previous research has shown that products formed as a result of metabolism can be measured in&#xD;
      breath and saliva (biomarkers). This has the ability to accurately identify patients with&#xD;
      upper gastrointestinal (UGI) cancers from breath. Our initial pilot data has demonstrated&#xD;
      that changes in the breakdown of metabolites release volatile organic compounds (VOC) which&#xD;
      can be measured with MS. This data is supported by other patient studies. However no previous&#xD;
      study has been performed utilising a non-invasive technique with breath and saliva. Thus the&#xD;
      aim of this study is to identify VOCs present in patients with this disease.&#xD;
&#xD;
      In this multi-centre study the investigators want to overcome the limitations of previous&#xD;
      work by utilising non-invasive samples (breath, saliva and urine) in patients in multiple&#xD;
      sites. The investigators aim to conduct a study in patients with UDC and those without. The&#xD;
      investigators hope that the results of this study will provide evidence for large scale&#xD;
      analysis of patients with this disease, demonstrate the feasibility of this technique and&#xD;
      move this valuable test forward into mainstream medical practice. The major advantage of this&#xD;
      test is that it is easy to undertake and painless for the patient. This study of products in&#xD;
      breath, saliva and urine will be useful for detecting UDC to allow treatment at an early&#xD;
      stage, improving overall survival.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 13, 2019</start_date>
  <completion_date type="Anticipated">September 13, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 13, 2024</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Non-invasive testing</measure>
    <time_frame>5 years</time_frame>
    <description>Samples such as exhaled breath, urine, saliva, tissue and blood will be obtained from patients. These will be analysed with mass spectrometry to identify the compounds changed in patients with the target disease and those without.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Squamous Cell Carcinoma</condition>
  <condition>Breath Test</condition>
  <condition>Digestive System Disease</condition>
  <condition>Diagnose Disease</condition>
  <arm_group>
    <arm_group_label>Oropharyngeal squamous cell carcinoma</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Oesophageal squamous cell carcinoma</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients recruited from secondary care will have been referred by their responsible&#xD;
        clinician to undergo either a laryngoscopy (which involves visualisation of the highest&#xD;
        part of the oesophagus, larynx and vocal cords, upper gastrointestinal endoscopy (which&#xD;
        involves a telescope test to visualise the oesophagus, stomach and duodenum) or a lower&#xD;
        gastrointestinal endoscopy (which involves a telescope test to visualise the colon) or&#xD;
        surgery. No other investigations will be required.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient who:&#xD;
&#xD;
               -  is ≥ 18 years old and below 90 years of age, AND:&#xD;
&#xD;
               -  is undergoing endoscopy as part of their routine clinical care, OR:&#xD;
&#xD;
               -  is undergoing surgical resection of orodigestive tract disease as part of their&#xD;
                  routine clinical care, OR:&#xD;
&#xD;
               -  is undergoing treatment of orodigestive tract disease as part of their routine&#xD;
                  clinical care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any patient who:&#xD;
&#xD;
               -  Lacks capacity or is unable to provide informed consent.&#xD;
&#xD;
               -  Any patient below 18 years of age or over 90 years of age.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yan Mei Goh, MBChB, MRCS</last_name>
    <phone>0207 594 3396</phone>
    <phone_ext>43396</phone_ext>
    <email>y.goh@imperial.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Imperial College London</name>
      <address>
        <city>London</city>
        <zip>W2 1NY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yan Mei Goh</last_name>
      <phone>0207 594 3396</phone>
      <phone_ext>43396</phone_ext>
      <email>y.goh@imperial.ac.uk</email>
    </contact>
    <investigator>
      <last_name>George B Hanna</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>November 16, 2020</last_update_submitted>
  <last_update_submitted_qc>November 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Digestive System Diseases</mesh_term>
    <mesh_term>Gastrointestinal Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04475952
org study id: IRAS 257483
nct id: NCT04475952
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Upper digestive tract cancer (UDC) is a major disease burden worldwide encompassing all
      cancers involving the digestive tract (from oral cavity to duodenum). A majority of patients
      presenting with this disease are diagnosed late and have poor overall survival rates (<20%).
      NICE referral guidelines for diagnostic endoscopy are usually associated with late disease.
      Exhaled breath testing is a non-invasive and acceptable technology utilising mass
      spectrometry (MS) which has shown promise at diagnosing cancer at an early stage.

      Previous research has shown that products formed as a result of metabolism can be measured in
      breath and saliva (biomarkers). This has the ability to accurately identify patients with
      upper gastrointestinal (UGI) cancers from breath. Our initial pilot data has demonstrated
      that changes in the breakdown of metabolites release volatile organic compounds (VOC) which
      can be measured with MS. This data is supported by other patient studies. However no previous
      study has been performed utilising a non-invasive technique with breath and saliva. Thus the
      aim of this study is to identify VOCs present in patients with this disease.

      In this multi-centre study the investigators want to overcome the limitations of previous
      work by utilising non-invasive samples (breath, saliva and urine) in patients in multiple
      sites. The investigators aim to conduct a study in patients with UDC and those without. The
      investigators hope that the results of this study will provide evidence for large scale
      analysis of patients with this disease, demonstrate the feasibility of this technique and
      move this valuable test forward into mainstream medical practice. The major advantage of this
      test is that it is easy to undertake and painless for the patient. This study of products in
      breath, saliva and urine will be useful for detecting UDC to allow treatment at an early
      stage, improving overall survival.
observational model: Cohort
time perspective: Prospective
measure: Non-invasive testing
time frame: 5 years
description: Samples such as exhaled breath, urine, saliva, tissue and blood will be obtained from patients. These will be analysed with mass spectrometry to identify the compounds changed in patients with the target disease and those without.
arm group label: Oropharyngeal squamous cell carcinoma
arm group label: Oesophageal squamous cell carcinoma
arm group label: Control
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yan Mei Goh, MBChB, MRCS
phone: 0207 594 3396
phone ext: 43396
email: y.goh@imperial.ac.uk
facility: 
status: Recruiting
contact: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Digestive System Diseases
mesh term: Gastrointestinal Diseases
sharing ipd: No