Ignite Creation Date:
2024-05-06 @ 2:52 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02141945
Status:
COMPLETED
Last Update Posted:
2017-03-28
First Post:
2014-05-14
Brief Title:
Microbiome Test for the Detection of Colorectal Polyps and Cancer
Sponsor:
Metabiomics Corp
Organization:
Metabiomics Corp
Study Overview
Official Title:
Metabiomics Neoplasia Clinical Research Study
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose if this study is to measure the sensitivity specificity and accuracy of the Metabiomics Colon Polyp and Colorectal Cancer Assay for the non-invasive detection of colon polyps or colorectal cancer
Detailed Description:
The purpose of this study is to conduct clinical research to investigate the association of the gut microbiome with colonic neoplasia In this study patients will supply samples of their gut microbiome prior to scheduled colonoscopy the relative abundance of microbes from those samples will be used to predict the presence or absence of colon polyps or colorectal cancer Microbiome based predictions from blinded samples will be compared with colonoscopy and pathology results to quantify the sensitivity specificity and accuracy reported as of the Metabiomics Colon Polyp and Colorectal Cancer Assay for colon polyps The limited sample size is anticipated to be insufficient to quantify sensitivity to colorectal cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None