e-Nose and Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03488537
• Other study ID #: e-Nose and colorectal cancer
• Status: Completed
• Phase: N/A
• Start date: February 28, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2018
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: December 31, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Polyps

Intervention

Device:
• AeonoseTM
Breath test

Locations

Country	Name	City	State
Netherlands	Medisch spectrum Twente	Enschede	Twente

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity/specificity for CRC	Diagnostic accuracy of the Aeonose to detect CRC in terms of sensitivity and specificity	38 weeks
Secondary	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
Secondary	Sensitivity/specificity for detection of CRC and/or polyps before and after bowel preparation	Diagnostic accuracy, sensitivity/specificity/AUC	38 weeks