e-Nose and Colorectal Cancer
Primary Purpose
Colorectal Cancer, Polyps
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
AeonoseTM
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- 18 years or older
- Suspicion for (pre-)malignant lesions of the colon scheduled for colonoscopy
Exclusion Criteria:
- Subjects with other known malignancies
- Subjects with established inflammatory bowel disease
Sites / Locations
- Medisch spectrum Twente
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
patients referred for colonoscopy
Arm Description
All patients referred for colonoscopy where invited to participate in our study.
Outcomes
Primary Outcome Measures
sensitivity/specificity for CRC
Diagnostic accuracy of the Aeonose to detect CRC in terms of sensitivity and specificity
Secondary Outcome Measures
sensitivity/specificity for advanced adenomas and/or sessile serrated lesions.
Diagnostic accuracy of the Aeonose to detect polyps in terms of sensitivity and specificity
Sensitivity/specificity for detection of CRC and/or polyps before and after bowel preparation
Diagnostic accuracy, sensitivity/specificity/AUC
Full Information
NCT ID
NCT03488537
First Posted
March 21, 2018
Last Updated
March 12, 2020
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03488537
Brief Title
e-Nose and Colorectal Cancer
Official Title
Detection of Colorectal Cancer From Exhaled Air. Part II: Validation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 28, 2018 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Colorectal cancer (CRC) is the third most common new cancer diagnosis and a major cause of morbidity and mortality throughout the world. Early detection and treatment are critical factors in the course and prognosis of CRC, and screening programs have proven to be an important means to reduce both CRC related mortality and secondary economic burden.
The diagnostic accuracy of non-invasive screening tests is still limited and a follow-up colonoscopy is required for confirmation of the diagnosis. The faecal occult blood test (FIT) is the most commonly used fecal screening test worldwide, but sensitivity for CRC ranges between 53%-99% depending on the cut-off values used, whereas sensitivity for advanced adenomas is disturbingly low (39%-57%).
The aim of this study is to evaluate the diagnostic accuracy of the AeonoseTM to distuinguish people with CRC from healthy controls.
Detailed Description
Rationale: An electronic nose (eNose) is an artificial olfactory system that analyses volate organic compounds (VOCs) in exhaled breath. Exhaled human breath is mainly composed of inorganic compounds, inert gases and VOCs. VOCs are exhaled in very low concentrations and reflect pathological processes such as inflammation, oxidation, infection and neoplasms. The perspective is that metabolic and biochemical processes in several pathological situations cause different endogenous VOCs to arise, were they can serve as non-invasive biomarkers for certain diseases.
Primary objective: To evaluate the diagnostic accuracy of the AeonoseTM to distinguish the breathing pattern from patients with colorectal cancer from healthy controls using the previously established breathing pattern.
Secondary objecitves:
To evaluate the diagnostic accuracy of the AeonoseTM to distinguish the breathing pattern from patients with polyps (e.g. advanced adenomas, sessile serrated lesions).
To determine the influence of colonic cleansing (laxative use) on breathing patterns.
Study population: Adult patients referred for colonoscopy.
Estimated sample size: 66 patients with CRC.
Intervention: Participants will be asked to breath through the AeonoseTM for 5 minutes. There are no risks, nor benefits for the participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Polyps
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a Multi center prospective cohort study in subjects eligible for colonoscopy with suspicion for malignant or premalignant lesions of the colon.
Masking
None (Open Label)
Allocation
N/A
Enrollment
511 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients referred for colonoscopy
Arm Type
Other
Arm Description
All patients referred for colonoscopy where invited to participate in our study.
Intervention Type
Device
Intervention Name(s)
AeonoseTM
Intervention Description
Breath test
Primary Outcome Measure Information:
Title
sensitivity/specificity for CRC
Description
Diagnostic accuracy of the Aeonose to detect CRC in terms of sensitivity and specificity
Time Frame
38 weeks
Secondary Outcome Measure Information:
Title
sensitivity/specificity for advanced adenomas and/or sessile serrated lesions.
Description
Diagnostic accuracy of the Aeonose to detect polyps in terms of sensitivity and specificity
Time Frame
38 weeks
Title
Sensitivity/specificity for detection of CRC and/or polyps before and after bowel preparation
Description
Diagnostic accuracy, sensitivity/specificity/AUC
Time Frame
38 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older
Suspicion for (pre-)malignant lesions of the colon scheduled for colonoscopy
Exclusion Criteria:
Subjects with other known malignancies
Subjects with established inflammatory bowel disease
Facility Information:
Facility Name
Medisch spectrum Twente
City
Enschede
State/Province
Twente
ZIP/Postal Code
7512KZ
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
31858615
Citation
van Keulen KE, Jansen ME, Schrauwen RWM, Kolkman JJ, Siersema PD. Volatile organic compounds in breath can serve as a non-invasive diagnostic biomarker for the detection of advanced adenomas and colorectal cancer. Aliment Pharmacol Ther. 2020 Feb;51(3):334-346. doi: 10.1111/apt.15622. Epub 2019 Dec 20.
Results Reference
derived
Learn more about this trial
e-Nose and Colorectal Cancer
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