Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347887
Status:
COMPLETED
Last Update Posted:
2024-06-03
First Post:
2024-03-27
Brief Title:
Clinical Validation of ColonAiQ a Blood-based Assay Targeting ctDNA Methylation for Colorectal Cancer Detection
Sponsor:
Singlera Genomics Inc
Organization:
Singlera Genomics Inc
Study Overview
Official Title:
Clinical Validation of ColonAiQ a Blood-based Assay Targeting Circulating Tumor DNA Methylation for Colorectal Cancer Detection
Status:
COMPLETED
Status Verified Date:
2024-03
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 DNA methylation targets in preoperative plasma samples of the subjects will be detected by the multi-gene methylation test ColonAiQ and the test accuracy will be evaluated by compared with the clinical diagnosis evidence
Detailed Description:
The accuracy of ColonAiQ test in clinical testing will be evaluated in the multicenter prospective study Patients with colorectal cancer intestinal polyps adenomas and other non-neoplastic diseases of the digestive system and patients with non-colorectal cancer such as gastric cancer esophageal cancer breast cancer and lung cancer will be enrolled In this study all cfDNA will be tested by fluorescence quantitative PCR and some samples will be tested by NGS to verify the effectiveness of ColonAiQ test Clinical diagnosis reports and methylation test results will be blinded to the lab tester and clinician respectively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None