Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-27 @ 2:42 PM
Study NCT ID:
NCT06304168
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2024-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of DNA Methylation Markers for Universal and Site-specific Guided Cancer Detection, VANGUARD Study
Sponsor:
Mayo Clinic
Organization:
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:
2025-09
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, and/or 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, and/or residual tissue sample collection and have their medical records reviewed on study.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: