Colorectal Cancer Clinical Trial
— SCREENEROfficial title:
Breath analysiS as an Additional Test for ColoREctal cancEr screeNing to rEduce the Number of unnecessaRy Colonoscopies
NCT number | NCT04357158 |
Other study ID # | '2020-6184' |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 25, 2020 |
Est. completion date | July 5, 2022 |
Verified date | September 2021 |
Source | Radboud University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In the past decade, the demand for colonoscopy procedures has increased significantly since the introduction of population-based colorectal cancer (CRC) screening in many western countries. Post-polypectomy surveillance will increase the number of colonoscopy procedures conducted each year even further. The invasive nature of colonoscopy and the associated health-care costs warrant the development of a new non-invasive test to reduce the number of unnecessary colonoscopies. These days, many countries use a non-invasive fecal test for CRC screening which is easy to perform at home, but test characteristics such as sensitivity and specificity are suboptimal. Multiple studies have already shown that volatile organic compound (VOC) analysis has a high diagnostic accuracy for CRC and Advanced Adenomas. An additional VOC analysis, for example through breath testing, in patients with a positive fecal immunochemical test (FIT) may reduce the number of unnecessary colonoscopies. The aim of this study is to validate the diagnostic accuracy of the AeonoseTM to distinguish patients with CRC from healthy controls, and to assess reproducibility of test results.
Status | Completed |
Enrollment | 750 |
Est. completion date | July 5, 2022 |
Est. primary completion date | January 5, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 75 Years |
Eligibility | Inclusion Criteria: - Adult patients between the ages of 55 and 75 years referred for a colonoscopy procedure after a positive FIT test, according to the population based CRC screening program in the Netherlands Exclusion Criteria: - Prior surgical resection of any portion of the colon - History of any type of malignancy, not including squamous cell carcinoma (SCC) and basal cell carcinoma (BCC) - Current active colitis or history of polyposis syndrome |
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboud university medical center | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Radboud University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic accuracy in distinguishing colorectal carcinoma from healthy controls | The diagnostic accuracy, in terms of sensitivity and specificity, of the AeonoseTM in distinguishing between patients with and without CRC. | 12 months | |
Secondary | Diagnostic accuracy in distinguishing advanced adenoma from healthy controls | Sensitivity and specificity | 12 months | |
Secondary | Reproducibility | The variation in VOC analysis results between two separate time points. The binary results from the eNose analysis will be presented in a scatterplot and a receiver operating characteristics curve (ROC-curve). Cohen's kappa statistic will be applied to determine interobserver agreement between the eNose results of 2 different timepoints (>2 weeks apart) | 12 months | |
Secondary | Acceptance rate | The acceptance rate of using the AeonoseTM in participating patients. | 12 months |
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