e-Nose and Colorectal Cancer
NCT03488537 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 511
Last updated 2020-03-16
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
Interventions
- DEVICE
-
AeonoseTM
Breath test
Sponsors & Collaborators
-
Radboud University Medical Center
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-02-28
- Primary Completion
- 2019-11-30
- Completion
- 2019-12-31
Countries
- Netherlands
Study Locations
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