e-Nose and Colorectal Cancer

Detection of Colorectal Cancer From Exhaled Air. Part II: Validation

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Polyps
• Intervention / Treatment: Device: AeonoseTM

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.

• Study Type: Interventional
• Enrollment (Actual): 511
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Twente
    • Enschede, Twente, Netherlands, 7512KZ
      • Medisch Spectrum Twente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: patients referred for colonoscopy; All patients referred for colonoscopy where invited to participate in our study.	Device: AeonoseTM; Breath test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sensitivity/specificity for CRC	Diagnostic accuracy of the Aeonose to detect CRC in terms of sensitivity and specificity	38 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sensitivity/specificity for advanced adenomas and/or sessile serrated lesions.	Diagnostic accuracy of the Aeonose to detect polyps in terms of sensitivity and specificity	38 weeks
Sensitivity/specificity for detection of CRC and/or polyps before and after bowel preparation	Diagnostic accuracy, sensitivity/specificity/AUC	38 weeks

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 28, 2018
• Primary Completion (ACTUAL): November 30, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: March 28, 2018
• First Posted (ACTUAL): April 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 16, 2020
• Last Update Submitted That Met QC Criteria: March 12, 2020
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: e-Nose and colorectal cancer

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No