<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/NCT04407416</url>
  </required_header>
  <id_info>
    <org_study_id>27/2020</org_study_id>
    <nct_id>NCT04407416</nct_id>
  </id_info>
  <brief_title>VOCs vs FIT for Colorectal Cancer Screening</brief_title>
  <official_title>The Effectiveness of Breath Analysis Versus FIT for Colorectal Cancer Screening</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Societa Italiana di Chirurgia ColoRettale</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Societa Italiana di Chirurgia ColoRettale</source>
  <oversight_info>
    <has_dmc>No</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>
      Endogenous breath VOCs (Volatile Organic Compounds) are present in various excreted&#xD;
      biological materials (urine, blood, faeces an breath) and their analysis offers a possibility&#xD;
      for cancer screening. Some of these VOCs are reversed in the venous blood stream and reach&#xD;
      the lung alveoli where some of them are exhaled.&#xD;
&#xD;
      Colorectal cancer (CRC) is one of the commonest tumours and is an important cause of&#xD;
      cancer-related mortality. Colonoscopy is the gold standard for the diagnosis of CRC.&#xD;
&#xD;
      Screening with fecal immunochemical test (FIT) is associated with a 13-18% CRC-mortality&#xD;
      reduction.&#xD;
&#xD;
      Aim of the study To compare the reliability of this breath analysis with&#xD;
      Immunochemically-based Fecal Occult Blood Test.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Volatile organic compounds (VOCs) are low molecular weight (&lt;1 kDa) compounds which represent&#xD;
      the final products of cell metabolism. Their composition can be affected by several factors&#xD;
      including diet, hormones, environment and the presence of diseases, in particular, cancer.&#xD;
&#xD;
      Endogenous breath VOCs are present in various excreted biological materials (urine, blood,&#xD;
      faeces an breath) and their analysis offers a possibility for cancer screening. Some of these&#xD;
      VOCs are reversed in the venous blood stream and reach the lung alveoli where some of them&#xD;
      are exhaled.&#xD;
&#xD;
      Colorectal cancer (CRC) is one of the commonest tumours and is an important cause of&#xD;
      cancer-related mortality. Colonoscopy is the gold standard for the diagnosis of CRC, although&#xD;
      its cost prevents its use for mass screening. Furthermore colonoscopy is not well accepted by&#xD;
      patients since it is an invasive exam. Screening with fecal immunochemical test (FIT) is&#xD;
      associated with a 13-18% CRC-mortality reduction in major randomized studies and is the most&#xD;
      widely used non-invasive screening tool, showing fairly good specificity but a high variation&#xD;
      in sensitivity (61-91%) and adherence to screening programmes rarely reaches 50-70% of the&#xD;
      target population.&#xD;
&#xD;
      Recently the breath analysis has been demonstrated to be a new well accepted and non-invasive&#xD;
      tool to detect colorectal cancer.&#xD;
&#xD;
      The purpose of this trial is to compare the reliability of this breath analysis with&#xD;
      Immunochemically-based Fecal Occult Blood Test, which is the routinely employed tool for mass&#xD;
      screening. A group of subjects adherent to the regional screening program for colorectal&#xD;
      cancer prevention, who resulted positive to the FIT, will be enrolled in this study, and will&#xD;
      have a breath sampling before undergoing colonoscopy. The predictive ability of the Breath&#xD;
      test will be tested in a blind fashion in this selected group of high-risk subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 2, 2020</start_date>
  <completion_date type="Anticipated">May 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">May 2, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>FIT sensitivity</measure>
    <time_frame>30 days</time_frame>
    <description>Evaluate the sensitivity of fecal immunochemical test to detect Colorectal cancer patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Breath analysis sensitivity</measure>
    <time_frame>30 days</time_frame>
    <description>Evaluate the sensitivity Breath analysis to detect colorectal cancer patients</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Colorectal Polyp</condition>
  <arm_group>
    <arm_group_label>Healthy subjects</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The breath of all patients with positive FIT (fecal immunochemical test) but negative colonoscopy will be sampled using a breath sampler</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Colorectal Cancer patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The breath of all patients with positive FIT (fecal immunochemical test) and a colorectal cancer detected by colonoscopy will be sampled using a breath sampler</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Colonic Polyps patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The breath of all patients with positive FIT (fecal immunochemical test) and a colonic polyp detected by colonoscopy will be sampled using a breath sampler</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Breath sampling</intervention_name>
    <description>The breath of all subjects included will be sampled using a device able to capture the alveolar air and to fix it on carbon tubes, Then the tubes will be desorbed and analysed using gas chromatography</description>
    <arm_group_label>Colonic Polyps patients</arm_group_label>
    <arm_group_label>Colorectal Cancer patients</arm_group_label>
    <arm_group_label>Healthy subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with and without positive FIT with a planned colonoscopy&#xD;
&#xD;
          -  Patients included in the regional screening program for CRC&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Inflammatory bowel disease&#xD;
&#xD;
          -  Bowel prep&#xD;
&#xD;
          -  Any psychiatric disease&#xD;
&#xD;
          -  Previous (or still present) cancers in other organs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elisabetta Martinelli, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Societa Italiana di Chirurgia ColoRettale</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Donato Altomare, Prof</last_name>
    <phone>+393397593066</phone>
    <email>donatofrancesco.altomare@uniba.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Arcangelo Picciariello, MD</last_name>
    <phone>+393492185104</phone>
    <email>arcangelopicciariello@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dept of Emergency and Organ transplantation</name>
      <address>
        <city>Bari</city>
        <zip>70124</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Donato F Altomare, MD</last_name>
      <phone>00390805478764</phone>
      <email>altomare@clichiru.uniba.it</email>
    </contact>
    <investigator>
      <last_name>Donato F Altomare, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Arcangelo Picciariello, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Bond A, Greenwood R, Lewis S, Corfe B, Sarkar S, O'Toole P, Rooney P, Burkitt M, Hold G, Probert C. Volatile organic compounds emitted from faeces as a biomarker for colorectal cancer. Aliment Pharmacol Ther. 2019 Apr;49(8):1005-1012. doi: 10.1111/apt.15140. Epub 2019 Mar 3.</citation>
    <PMID>30828825</PMID>
  </results_reference>
  <results_reference>
    <citation>Altomare DF, Di Lena M, Porcelli F, Trizio L, Travaglio E, Tutino M, Dragonieri S, Memeo V, de Gennaro G. Exhaled volatile organic compounds identify patients with colorectal cancer. Br J Surg. 2013 Jan;100(1):144-50. doi: 10.1002/bjs.8942.</citation>
    <PMID>23212621</PMID>
  </results_reference>
  <results_reference>
    <citation>Stracci F, Zorzi M, Grazzini G. Colorectal cancer screening: tests, strategies, and perspectives. Front Public Health. 2014 Oct 27;2:210. doi: 10.3389/fpubh.2014.00210. eCollection 2014.</citation>
    <PMID>25386553</PMID>
  </results_reference>
  <results_reference>
    <citation>Mousavinezhad M, Majdzadeh R, Akbari Sari A, Delavari A, Mohtasham F. The effectiveness of FOBT vs. FIT: A meta-analysis on colorectal cancer screening test. Med J Islam Repub Iran. 2016 May 9;30:366. eCollection 2016.</citation>
    <PMID>27493910</PMID>
  </results_reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 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>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04407416
org study id: 27/2020
nct id: NCT04407416
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Endogenous breath VOCs (Volatile Organic Compounds) are present in various excreted
      biological materials (urine, blood, faeces an breath) and their analysis offers a possibility
      for cancer screening. Some of these VOCs are reversed in the venous blood stream and reach
      the lung alveoli where some of them are exhaled.

      Colorectal cancer (CRC) is one of the commonest tumours and is an important cause of
      cancer-related mortality. Colonoscopy is the gold standard for the diagnosis of CRC.

      Screening with fecal immunochemical test (FIT) is associated with a 13-18% CRC-mortality
      reduction.

      Aim of the study To compare the reliability of this breath analysis with
      Immunochemically-based Fecal Occult Blood Test.
Volatile organic compounds (VOCs) are low molecular weight (<1 kDa) compounds which represent
      the final products of cell metabolism. Their composition can be affected by several factors
      including diet, hormones, environment and the presence of diseases, in particular, cancer.

      Endogenous breath VOCs are present in various excreted biological materials (urine, blood,
      faeces an breath) and their analysis offers a possibility for cancer screening. Some of these
      VOCs are reversed in the venous blood stream and reach the lung alveoli where some of them
      are exhaled.

      Colorectal cancer (CRC) is one of the commonest tumours and is an important cause of
      cancer-related mortality. Colonoscopy is the gold standard for the diagnosis of CRC, although
      its cost prevents its use for mass screening. Furthermore colonoscopy is not well accepted by
      patients since it is an invasive exam. Screening with fecal immunochemical test (FIT) is
      associated with a 13-18% CRC-mortality reduction in major randomized studies and is the most
      widely used non-invasive screening tool, showing fairly good specificity but a high variation
      in sensitivity (61-91%) and adherence to screening programmes rarely reaches 50-70% of the
      target population.

      Recently the breath analysis has been demonstrated to be a new well accepted and non-invasive
      tool to detect colorectal cancer.

      The purpose of this trial is to compare the reliability of this breath analysis with
      Immunochemically-based Fecal Occult Blood Test, which is the routinely employed tool for mass
      screening. A group of subjects adherent to the regional screening program for colorectal
      cancer prevention, who resulted positive to the FIT, will be enrolled in this study, and will
      have a breath sampling before undergoing colonoscopy. The predictive ability of the Breath
      test will be tested in a blind fashion in this selected group of high-risk subjects.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: FIT sensitivity
time frame: 30 days
description: Evaluate the sensitivity of fecal immunochemical test to detect Colorectal cancer patients
measure: Breath analysis sensitivity
time frame: 30 days
description: Evaluate the sensitivity Breath analysis to detect colorectal cancer patients
arm group label: Healthy subjects
arm group type: Active Comparator
description: The breath of all patients with positive FIT (fecal immunochemical test) but negative colonoscopy will be sampled using a breath sampler
arm group label: Colorectal Cancer patients
arm group type: Active Comparator
description: The breath of all patients with positive FIT (fecal immunochemical test) and a colorectal cancer detected by colonoscopy will be sampled using a breath sampler
arm group label: Colonic Polyps patients
arm group type: Active Comparator
description: The breath of all patients with positive FIT (fecal immunochemical test) and a colonic polyp detected by colonoscopy will be sampled using a breath sampler
intervention type: Procedure
intervention name: Breath sampling
description: The breath of all subjects included will be sampled using a device able to capture the alveolar air and to fix it on carbon tubes, Then the tubes will be desorbed and analysed using gas chromatography
arm group label: Colonic Polyps patients
arm group label: Colorectal Cancer patients
arm group label: Healthy subjects
criteria: 
gender: All
minimum age: 35 Years
maximum age: 85 Years
healthy volunteers: No
last name: Elisabetta Martinelli, MD
role: Study Chair
affiliation: Societa Italiana di Chirurgia ColoRettale
last name: Donato Altomare, Prof
phone: +393397593066
email: donatofrancesco.altomare@uniba.it
last name: Arcangelo Picciariello, MD
phone: +393492185104
email: arcangelopicciariello@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Italy
citation: Bond A, Greenwood R, Lewis S, Corfe B, Sarkar S, O'Toole P, Rooney P, Burkitt M, Hold G, Probert C. Volatile organic compounds emitted from faeces as a biomarker for colorectal cancer. Aliment Pharmacol Ther. 2019 Apr;49(8):1005-1012. doi: 10.1111/apt.15140. Epub 2019 Mar 3.
PMID: 30828825
citation: Altomare DF, Di Lena M, Porcelli F, Trizio L, Travaglio E, Tutino M, Dragonieri S, Memeo V, de Gennaro G. Exhaled volatile organic compounds identify patients with colorectal cancer. Br J Surg. 2013 Jan;100(1):144-50. doi: 10.1002/bjs.8942.
PMID: 23212621
citation: Stracci F, Zorzi M, Grazzini G. Colorectal cancer screening: tests, strategies, and perspectives. Front Public Health. 2014 Oct 27;2:210. doi: 10.3389/fpubh.2014.00210. eCollection 2014.
PMID: 25386553
citation: Mousavinezhad M, Majdzadeh R, Akbari Sari A, Delavari A, Mohtasham F. The effectiveness of FOBT vs. FIT: A meta-analysis on colorectal cancer screening test. Med J Islam Repub Iran. 2016 May 9;30:366. eCollection 2016.
PMID: 27493910
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
sharing ipd: Undecided