Validation of DNA Methylation Markers for the Universal and Site-Specific Guided Cancer Detection (the VANGUARD Study)
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.
Arms & interventions
- OtherNon-Interventional Study
Non-interventional study
Outcome measures
Primary
Overall cancer (Y/N) - blood test
Blood samples will be assayed for known cancer markers to explore the potential value of a new blood test approach to detecting cancer. Accuracy of results may be evaluated based on review of past, present, and future medical record information.
Time frame: Baseline (samples collected at enrollment)
Overall cancer (Y/N) - urine test
Urine samples will be assayed for known cancer markers to explore the potential value of a new urine test approach to detecting cancer. Accuracy of results may be evaluated based on review of past, present, and future medical record information.
Time frame: Baseline (samples collected at enrollment)
Cancer specific site prediction - blood samples/MDM
Blood samples will be assayed for methylated DNA markers (MDMs) to identify individual organ sites of primary tumors.
Time frame: Baseline (samples collected at enrollment)
Cancer specific site prediction - urine samples/MDM
Urine samples will be assayed for methylated DNA markers (MDMs) to identify individual organ sites of primary tumors.
Time frame: Baseline (samples collected at enrollment)
Cancer specific site prediction - blood samples/RNA
Blood samples will be assayed for ribonucleic acid (RNA) to identify individual organ sites of primary tumors.
Time frame: Baseline (samples collected at enrollment)
Cancer specific site prediction - urine samples/RNA
Urine samples will be assayed for ribonucleic acid (RNA) to identify individual organ sites of primary tumors.
Time frame: Baseline (samples collected at enrollment)
Eligibility criteria
Study locations (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905