Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649123
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Triple Assay of Rectal Mucus in the Diagnosis of Colorectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development of a Multiomics Assay for Use on OriColTM Sampled Rectal Mucus for Detection of Cancer and Significant Polyps in Symptomatic Patients on the Colorectal Urgent Suspected Cancer Pathway
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIOMIC
Brief Summary:
Development of a multiomics assay for use on OriColTM sampled rectal mucus for detection of cancer and significant polyps in symptomatic patients on the Colorectal Urgent Suspected Cancer pathway
Detailed Description:
The primary objectives of the study are
1 Confirm the presence of established genetic epigenetic and microbiome based biomarker signatures associated with CRC and high-risk adenoma defined as 10mm in diameter or the presence of high-grade dysplasia in colorectal urgent suspected cancer referrals who are triaged for colonoscopy
2 To expand and refine the genomic epigenetic and microbiome biomarker signature profiles associated with colorectal cancer and high-risk adenoma to identify rarer biomarkers in addition to those previously established
3 To generate indicative performance metrics including an assessment of discriminatory power sensitivity specificity and negative predictive values for the clinical application of Oricol multiomics assay
The Secondary Objectives of the study are
1 To assess the health economics of delivering a diagnostic service to patients referred to the urgent suspected cancer USC pathway via a Community Diagnostic Centre CDC in comparison to the current delivery mechanisms through the Two-Week Wait TWW pathway
1 Confirm the presence of established genetic epigenetic and microbiome based biomarker signatures associated with CRC and high-risk adenoma defined as 10mm in diameter or the presence of high-grade dysplasia in colorectal urgent suspected cancer referrals who are triaged for colonoscopy
2 To expand and refine the genomic epigenetic and microbiome biomarker signature profiles associated with colorectal cancer and high-risk adenoma to identify rarer biomarkers in addition to those previously established
3 To generate indicative performance metrics including an assessment of discriminatory power sensitivity specificity and negative predictive values for the clinical application of Oricol multiomics assay
The Secondary Objectives of the study are
1 To assess the health economics of delivering a diagnostic service to patients referred to the urgent suspected cancer USC pathway via a Community Diagnostic Centre CDC in comparison to the current delivery mechanisms through the Two-Week Wait TWW pathway
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