Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304168
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-27
Brief Title:
Validation of DNA Methylation Markers for Universal and Site-specific Guided Cancer Detection VANGUARD Study
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Validation of DNA Methylation Markers for the Universal and Site-Specific Guided Cancer Detection the VANGUARD Study
Status:
RECRUITING
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:
This study explores the potential value of a new blood test approach for early detection of cancer
Detailed Description:
PRIMARY OBJECTIVES
I Validate candidate universal and site-specific MDMs in DNA extracted from formalin-fixed paraffin embedded primary tumor and control specimens
II Test MDM-based models for detection of the top 16 most lethal human cancers using a non-invasive biological medium specifically blood
III Assess feasibility for detection of cancers using urine samples to assay MDMs RNA or protein in cell free or extra-cellular vesicles patients may be the same or unique individuals from Aim 1 and 2
OUTLINE This is an observational study
Patients undergo blood urine andor residual tissue sample collection and have their medical records reviewed on study
I Validate candidate universal and site-specific MDMs in DNA extracted from formalin-fixed paraffin embedded primary tumor and control specimens
II Test MDM-based models for detection of the top 16 most lethal human cancers using a non-invasive biological medium specifically blood
III Assess feasibility for detection of cancers using urine samples to assay MDMs RNA or protein in cell free or extra-cellular vesicles patients may be the same or unique individuals from Aim 1 and 2
OUTLINE This is an observational study
Patients undergo blood urine andor residual tissue sample collection and have their medical records reviewed on study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 19-000890 | OTHER | Mayo Clinic Institutional Review Board | None |
| NCI-2024-00954 | REGISTRY | None | None |