Clinical trial NCT03488537: e-Nose and Colorectal Cancer
Official title: Detection of Colorectal Cancer From Exhaled Air. Part II: Validation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Polyps
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 511
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: sensitivity/specificity for CRC
timeFrame: 38 weeks
Secondary outcomes:
measure: sensitivity/specificity for advanced adenomas and/or sessile serrated lesions.
timeFrame: 38 weeks
measure: Sensitivity/specificity for detection of CRC and/or polyps before and after bowel preparation
timeFrame: 38 weeks
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Medisch spectrum Twente
state: Twente
Study officials:
References:
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.