e-Nose and Colorectal Cancer

NCT03488537 | Completed

• 1 other identifier: e-Nose and colorectal cancer
• Study Type: interventional
• Target: 511
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Polyps

Outcome Measures

Primary Outcomes (1)

• sensitivity/specificity for CRC

  Diagnostic accuracy of the Aeonose to detect CRC in terms of sensitivity and specificity

  38 weeks

Secondary Outcomes (2)

• sensitivity/specificity for advanced adenomas and/or sessile serrated lesions.

  38 weeks

• Sensitivity/specificity for detection of CRC and/or polyps before and after bowel preparation

  38 weeks

Study Arms (1)

patients referred for colonoscopy

OTHER

All patients referred for colonoscopy where invited to participate in our study.

Device: AeonoseTM

Interventions

AeonoseTM DEVICE

Breath test

patients referred for colonoscopy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Suspicion for (pre-)malignant lesions of the colon scheduled for colonoscopy

You may not qualify if:

• Subjects with other known malignancies
• Subjects with established inflammatory bowel disease

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Medisch spectrum Twente

Enschede, Twente, 7512KZ, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 31858615 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Polyps

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a Multi center prospective cohort study in subjects eligible for colonoscopy with suspicion for malignant or premalignant lesions of the colon.

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: April 5, 2018
• Study Start: February 28, 2018
• Primary Completion: November 30, 2019
• Study Completion: December 31, 2019
• Last Updated: March 16, 2020

Record last verified: 2018-02

Locations

NL (1)