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The Colorectal Breath Analysis (COBRA) Study (COBRA)

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ClinicalTrials.gov Identifier: NCT03699163
Recruitment Status : Recruiting
First Posted : October 8, 2018
Last Update Posted : October 8, 2018
Sponsor:
Collaborator:
Rosetrees Trust
Information provided by (Responsible Party):
Imperial College London

Brief Summary:

This study aims to determine whether a breath test could be used for early detection of colorectal cancer and colorectal polyps.

Patients who are attending for a planned colonoscopy or who are scheduled to undergo elective resection of histologically confirmed colorectal cancer (adenocarcinoma) will be approached to provide a breath sample.

Multi platform mass spectrometry analysis will be performed to establish volatile biomarkers that can discriminate between colorectal cancer, benign colorectal disease (e.g. polyps) and healthy controls.


Condition or disease Intervention/treatment
Colorectal Cancer Colorectal Polyps Colorectal Adenocarcinoma Diagnostic Test: Breath sample

Detailed Description:

Colorectal cancer is the 2nd most common cause of cancer death in the UK where survival rates are among the lowest in Europe. If diagnosed early survival may exceed 90%.

The proposed breath test is a non-invasive investigation that can detect the presence of volatile organic compounds (VOCs) in breath and their relative abundance in disease states including colorectal cancer. This test has potential to be used in a primary care setting to identify patients at high risk of colorectal cancer, supporting earlier referral for definitive investigation. A negative test may provide reassurance to patients and prevent unnecessary tests in this group. The test could also have an application for colorectal cancer screening.

In this study the investigators will determine the diagnostic accuracy of an exhaled breath test for the detection of colorectal adenocarcinoma and colonic polyps. To determine the accuracy of the breath test a multicentre cross-sectional study will be conducted to analyse single breath samples from patients attending hospital for planned colonoscopy or elective resection of histologically confirmed colorectal cancer. The target for the study is 1463 patients.

Breath collection will be conducted using a previously validated method. Samples of breath (500ml) collected using a CE-marked handheld ReCIVA sampling device (Owlstone Medical Ltd., Cambridge, UK) during a period of tidal breathing (approximately 5minutes) will be absorbed onto thermal desorption tubes (Markes International, Llantrisant, UK). All patients will have received bowel preparation and will be fasted for a minimum of 6 hours prior to the breath sample. Breath samples collected within thermal desorption tubes will be transferred to a central laboratory for analysis by gas chromatography mass spectrometry (GC-MS) and proton transfer reaction time of flight mass spectrometry (PTR-ToF-MS). Raw data files will be extracted and analysed in accordance with established protocols. Quality assurance measures will be formally assessed at each stage of sample handling.


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Study Type : Observational
Estimated Enrollment : 1463 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Non-invasive Testing for the Diagnosis and Assessment of Colorectal Disease
Actual Study Start Date : June 3, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Endoscopy patients
Patients who are attending hospital for a colonoscopy as part of their routine clinical care, or as part of the Bowel Cancer Screening Programme, will be asked to give a sample of their breath prior to the procedure.
Diagnostic Test: Breath sample
Patients will be asked to give a sample of their breath, using the ReCIVA breath testing device. This involves performing tidal breathing whilst wearing a face mask for approximately 5 minutes. Breath (500mls at a flow rate of 200mls/min) is passed over thermal desorption tubes which absorb compounds of interest.

Colorectal cancer patients
Patients who have known pre-diagnosed colorectal cancer (adenocarcinoma) attending hospital as part of their clinical care will be asked to give a breath sample prior to their cancer operation.
Diagnostic Test: Breath sample
Patients will be asked to give a sample of their breath, using the ReCIVA breath testing device. This involves performing tidal breathing whilst wearing a face mask for approximately 5 minutes. Breath (500mls at a flow rate of 200mls/min) is passed over thermal desorption tubes which absorb compounds of interest.




Primary Outcome Measures :
  1. Determine the diagnostic accuracy of the proposed breath test for detection of colorectal cancer and colorectal polyps. [ Time Frame: 4 years ]
    Diagnostic accuracy will be measured by calculating the sensitivity and specificity of the test for detection of colorectal cancer and polyps. Sensitivity and specificity values are represented by a number between 0 to 1 indicating the test's ability to pick up true positive results and true negative results respectively, where a number closer to one indicates a greater detection ability.


Secondary Outcome Measures :
  1. Confirmation of diagnostic accuracy of the proposed breath test for early detection of colorectal cancer and for colorectal polyps. [ Time Frame: 2 years ]
    After diagnostic accuracy has been determined as per objective 1 by the discovery phase of the proposed study, a validation phase will then follow to confirm findings. Diagnostic accuracy of the validation phase results will be measured by calculating the sensitivity and specificity of the test for detection of colorectal cancer and polyps. Sensitivity and specificity values are represented by a number between 0 to 1 indicating the test's ability to pick up true positive results and true negative results respectively, where a number closer to one indicates a greater detection ability.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are attending for a planned colonoscopy or who are scheduled to undergo elective resection of histologically confirmed colorectal adenocarcinoma will be eligible for inclusion in this study
Criteria

Inclusion Criteria:

  • ≥18 years and ≤90 years of age
  • Undergoing planned colonoscopy or elective resection of histologically confirmed colorectal adenocarcinoma
  • Fasted >6 hours
  • Able to provide informed written consent

Exclusion Criteria:

  • Any patient <18 years or >90 years of age.
  • Lacks capacity or is unable to provide informed written consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699163


Contacts
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Contact: Georgia E Woodfield, MBChB MSc 07799578985 g.woodfield@imperial.ac.uk
Contact: George B Hanna, FRCS PhD 07766823177 g.hanna@imperial.ac.uk

Locations
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United Kingdom
Homerton Hospital Recruiting
London, United Kingdom, E9 6SR
Contact: Georgia E Woodfield, MBChB MSc    07799578985    g.woodfield@imperial.ac.uk   
St Mark's Hospital Recruiting
London, United Kingdom, HA1 3UJ
Contact: Georgia E Woodfield, MBChB MSc    07799578986    g.woodfield@imperial.ac.uk   
St George's Hospital Recruiting
London, United Kingdom, SW17 0RE
Contact: Georgia E Woodfield, MBChB MSc    07799578985    g.woodfield@imperial.ac.uk   
Chelsea and Westminster Hospital Recruiting
London, United Kingdom, SW19 9NH
Contact: Georgia E Woodfield, MBChB MSc    07799578985    g.woodfield@imperial.ac.uk   
Royal Marsden Hospital Not yet recruiting
London, United Kingdom, SW3 6JJ
Contact: Georgia Woodfield         
Contact       g.woodfield@imperial.ac.uk   
West Middlesex Hospital Recruiting
London, United Kingdom, TW7 6AF
Contact: Georgia E Woodfield, MBChB MSc    07799578985    g.woodfield@imperial.ac.uk   
St Mary's Hospital Recruiting
London, United Kingdom, W2 1NY
Contact: Georgia E Woodfield, MBChB Msc    07799578985    g.woodfield@imperial.ac.uk   
Principal Investigator: George B Hanna, MBChB FRCS PhD         
Charing Cross Hospital Recruiting
London, United Kingdom, W6 8RF
Contact: Georgia E Woodfield, MBChB Msc    07799578985    g.woodfield@imperial.ac.uk   
Principal Investigator: George B Hanna, MBChB FRCS PhD         
Sponsors and Collaborators
Imperial College London
Rosetrees Trust
Investigators
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Principal Investigator: George B Hanna, FRCS PhD Imperial College London

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03699163     History of Changes
Other Study ID Numbers: 17SM3783
First Posted: October 8, 2018    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Imperial College London:
Volatile organic compounds
Mass spectrometry
Early detection

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Intestinal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases
Carcinoma