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/NCT05977478</url>
    </required_header>
    <id_info>
      <org_study_id>2022/00489</org_study_id>
      <nct_id>NCT05977478</nct_id>
    </id_info>
    <brief_title>Characterization of Tissue Biochemical Composition in Gastric Precancerous/Cancerous Lesions</brief_title>
    <official_title>Characterization of Tissue Biochemical Composition in Gastric Precancerous/Cancerous Lesions</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National University Hospital, Singapore</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Endofotonics Pte Ltd</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>National University Hospital, Singapore</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 is a study intended to utilize endoscopic biopsies from gastric precancerous/ cancerous&#xD;
        lesions and adjacent normal mucosa to characterize tissue biochemical composition changes as&#xD;
        determined by mass spectrometry lipidomic/ proteomic profiling, and correlate these changes&#xD;
        with histopathologic results, and Raman spectra as determined by SPECTRA IMDx™. The study&#xD;
        site will be National University Hospital.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a study intended to utilize endoscopic biopsies from gastric precancerous/ cancerous&#xD;
        lesions and adjacent normal mucosa to characterize tissue biochemical composition changes as&#xD;
        determined by mass spectrometry lipidomic/ proteomic profiling, and correlate these changes&#xD;
        with histopathologic results, and Raman spectra as determined by SPECTRA IMDx™. The study&#xD;
        site will be National University Hospital. Subjects will be patients with current or known&#xD;
        history of gastric dysplasia and gastric cancer, or endoscopic surveillance after previous&#xD;
        endoscopic or surgical resection for gastric dysplasia or gastric cancer, for which upper&#xD;
        gastrointestinal endoscopy is indicated. Patients who meet the study criteria and have&#xD;
        consented to participate in the study will undergo upper gastrointestinal endoscopy&#xD;
        examination as per standard practice.&#xD;
  &#xD;
        During endoscopy, the endoscopist will first locate the precancerous/cancerous lesions using&#xD;
        HD-WLE. Upon location of the lesion, the endoscopist will use the SPECTRA IMDx™ probe to&#xD;
        capture the Raman spectra from the lesion and its adjacent normal mucosa. Two biopsies will&#xD;
        be obtained from the lesion, and two biopsies from adjacent normal mucosa at the exact sites&#xD;
        where the SPECTRA IMDx probe has been placed. One biopsy each from the lesion and from normal&#xD;
        mucosa will be sent for histopathologic examination. Another biopsy each from the lesion and&#xD;
        normal mucosa will be snap-freeze, stored in liquid nitrogen immediately, and transferred to&#xD;
        mass spectrometry service provider for lipidomic and proteomic profiling. Histopathology&#xD;
        results and mass spectrometry profiling results will be correlated to Raman spectra. Subjects&#xD;
        will receive the standard care assessments throughout the study according to the hospital's&#xD;
        standard procedures. No follow-up is needed in this study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 27, 2022</start_date>
    <completion_date type="Anticipated">March 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Correlating tissue biochemical composition with the Raman spectra and histopathologic results to differentiate between the gastric disease states based on distinct features in the biochemical composition of pre-cancerous / cancerous lesions.</measure>
      <time_frame>18 moths</time_frame>
      <description>To utilize endoscopic biopsies from gastric precancerous/ cancerous lesions and adjacent normal mucosa to characterize tissue biochemical composition changes as determined by mass spectrometry lipidomic/ proteomic profiling, and correlate these changes with histopathologic results, and Raman spectra as determined by SPECTRA IMDx™.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Gastric Cancer</condition>
    <arm_group>
      <arm_group_label>SPECTRA IMDx™.</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>During endoscopy, the endoscopist will first locate the precancerous/cancerous gastric lesions using HD-WLE. Upon location of the lesion, the endoscopist will use the SPECTRA IMDx™ probe to capture the Raman spectra from the lesion and its adjacent normal mucosa.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>SPECTRA IMDx™</intervention_name>
      <description>In this study, SPECTRA IMDxTM system will be used to capture the Raman spectra to correlate to histopathology results and mass spectrometry profiling results.</description>
      <arm_group_label>SPECTRA IMDx™.</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. They are aged 21 years and above&#xD;
  &#xD;
            2. They will be undergoing upper gastrointestinal endoscopy for any of the following:&#xD;
  &#xD;
                 1. Current or known history of gastric dysplasia and gastric cancer, or&#xD;
  &#xD;
                 2. Endoscopic surveillance after previous endoscopic or surgical resection for&#xD;
                    gastric dysplasia or gastric cancer.&#xD;
  &#xD;
            3. They must be mentally competent.&#xD;
  &#xD;
            4. They must be willing and able to comply with all study procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subjects with bleeding disorders, such as haemophilia, in whom biopsies are&#xD;
               contraindicated.&#xD;
  &#xD;
            2. Subjects with active bleeding or coagulopathy precluding biopsies.&#xD;
  &#xD;
            3. Pregnant subjects.&#xD;
  &#xD;
            4. The subject with severe co-morbid illness, such as end-stage renal failure (ESRF),&#xD;
               congestive cardiac failure (CCF) and advanced liver cirrhosis.&#xD;
  &#xD;
            5. Subjects with other severe acute or chronic medical or psychiatric condition or&#xD;
               laboratory abnormality that may interfere with the interpretation of study results or&#xD;
               would make the subject unsuitable for entry into the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Guowei Kim, MBBS</last_name>
      <role>Principal Investigator</role>
      <affiliation>National University Hospital, Singapore</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Guowei Kim, MBBS</last_name>
      <phone>+65-67725555</phone>
      <email>guo_wei_kim@nuhs.edu.sg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Bok Yan So, MBChB</last_name>
      <phone>+65-67725555</phone>
      <email>sursbyj@nus.edu.sg</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>National University Hospital</name>
        <address>
          <city>Singapore</city>
          <country>Singapore</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Guowei Kim, MBBS</last_name>
        <phone>+65-67725555</phone>
        <email>guo_wei_kim@nuhs.edu.sg</email>
      </contact>
    </location>
    <location_countries>
      <country>Singapore</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</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>Stomach Neoplasms</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/NCT05977478
  org study id: 2022/00489
  nct id: NCT05977478
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is a study intended to utilize endoscopic biopsies from gastric precancerous/ cancerous
        lesions and adjacent normal mucosa to characterize tissue biochemical composition changes as
        determined by mass spectrometry lipidomic/ proteomic profiling, and correlate these changes
        with histopathologic results, and Raman spectra as determined by SPECTRA IMDx™. The study
        site will be National University Hospital.
  This is a study intended to utilize endoscopic biopsies from gastric precancerous/ cancerous
        lesions and adjacent normal mucosa to characterize tissue biochemical composition changes as
        determined by mass spectrometry lipidomic/ proteomic profiling, and correlate these changes
        with histopathologic results, and Raman spectra as determined by SPECTRA IMDx™. The study
        site will be National University Hospital. Subjects will be patients with current or known
        history of gastric dysplasia and gastric cancer, or endoscopic surveillance after previous
        endoscopic or surgical resection for gastric dysplasia or gastric cancer, for which upper
        gastrointestinal endoscopy is indicated. Patients who meet the study criteria and have
        consented to participate in the study will undergo upper gastrointestinal endoscopy
        examination as per standard practice.
  
        During endoscopy, the endoscopist will first locate the precancerous/cancerous lesions using
        HD-WLE. Upon location of the lesion, the endoscopist will use the SPECTRA IMDx™ probe to
        capture the Raman spectra from the lesion and its adjacent normal mucosa. Two biopsies will
        be obtained from the lesion, and two biopsies from adjacent normal mucosa at the exact sites
        where the SPECTRA IMDx probe has been placed. One biopsy each from the lesion and from normal
        mucosa will be sent for histopathologic examination. Another biopsy each from the lesion and
        normal mucosa will be snap-freeze, stored in liquid nitrogen immediately, and transferred to
        mass spectrometry service provider for lipidomic and proteomic profiling. Histopathology
        results and mass spectrometry profiling results will be correlated to Raman spectra. Subjects
        will receive the standard care assessments throughout the study according to the hospital's
        standard procedures. No follow-up is needed in this study.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Correlating tissue biochemical composition with the Raman spectra and histopathologic results to differentiate between the gastric disease states based on distinct features in the biochemical composition of pre-cancerous / cancerous lesions.
  time frame: 18 moths
  description: To utilize endoscopic biopsies from gastric precancerous/ cancerous lesions and adjacent normal mucosa to characterize tissue biochemical composition changes as determined by mass spectrometry lipidomic/ proteomic profiling, and correlate these changes with histopathologic results, and Raman spectra as determined by SPECTRA IMDx™.
  arm group label: SPECTRA IMDx™.
  arm group type: Experimental
  description: During endoscopy, the endoscopist will first locate the precancerous/cancerous gastric lesions using HD-WLE. Upon location of the lesion, the endoscopist will use the SPECTRA IMDx™ probe to capture the Raman spectra from the lesion and its adjacent normal mucosa.
  intervention type: Device
  intervention name: SPECTRA IMDx™
  description: In this study, SPECTRA IMDxTM system will be used to capture the Raman spectra to correlate to histopathology results and mass spectrometry profiling results.
  arm group label: SPECTRA IMDx™.
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Guowei Kim, MBBS
  role: Principal Investigator
  affiliation: National University Hospital, Singapore
  last name: Guowei Kim, MBBS
  phone: +65-67725555
  email: guo_wei_kim@nuhs.edu.sg
  last name: Bok Yan So, MBChB
  phone: +65-67725555
  email: sursbyj@nus.edu.sg
  facility: 
  status: Recruiting
  contact: 
  country: Singapore
  responsible party type: Sponsor
  mesh term: Stomach Neoplasms
  sharing ipd: No