e-Nose and Colorectal Cancer | NCT03488537

Studies
e-Nose and Colorectal Cancer

NCT03488537

Sponsor

Radboud University Medical Center

Status

Completed

Last Update Posted

Mar 16, 2020Actual

Enrollment

511Actual

Phase

Not Applicable

Conditions

Colorectal Cancer
Polyps

Interventions

AeonoseTM

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2018Actual

Primary Completion Date

Nov 30, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Mar 21, 2018

First Submission Date that Met QC Criteria

Mar 28, 2018

First Posted Date

Apr 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2020

Last Update Posted Date

Mar 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

511Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients referred for colonoscopy	Other	All patients referred for colonoscopy where invited to participate in our study.	Device: AeonoseTM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AeonoseTM	Device	Breath test	patients referred for colonoscopy

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medisch spectrum Twente		Enschede	Twente	7512KZ	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31858615	Derived	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.

ID	Term
D015179	Colorectal Neoplasms
D011127	Polyps

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site