Multi-Cancer Detection Observational Cohort Study
Summary
This study assesses the incorporation of Multi-Cancer Detection (MCD) testing, designed to detect many types of cancer, into clinical practice to understand both its use and effect in real world practice conditions.
Arms & interventions
- ProcedureBlood Sample
Up to 60 mL (about 4-5 Tbsp) of blood may be collected for an initial blood draw and up to 30 mL (about 2-3 Tbsp) may be collected for a second blood draw, 25-45 days after first blood draw. The research blood will be collected at the time of a clinical blood draw, if possible.
- OtherSurveys
Participants will complete surveys related to attitudes and beliefs around Multi-Cancer Detection testing.
Outcome measures
Primary
Financial impact of MCD testing
Assessed by types of diagnostic studies ordered as a result of positive MCD test results (e.g., to establish or rule out a cancer diagnosis).
Time frame: Up to 5 years
Positive actionable MCD results
Assessed by the number of participants who receive positive MCD results
Time frame: Up to 5 years
Psychological Impact of MCD Testing
Assessed with the Multidimensional Impact of Cancer Risk Assessment (Adapted MICRA), which asks participants to evaluate their response to MCD test results over the past week. The MICRA consists of 20 items answered on a 4-point scale (Never, Rarely, Sometimes, Often). Higher scores generally indicate higher levels of distress or psychological impact.
Time frame: Baseline (after receiving MCD results)
Change in Patient Satisfaction with MCD Test
Participants will complete a 3-question survey, "Satisfaction with the Multi-Cancer Detection Test." Items are answered on a 5-point scale (not at all, a little, somewhat, very, extremely).
Time frame: Baseline; After receiving MCD results (up to 5 years)
Eligibility criteria
Study locations (3)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Mayo Clinic in Rochester
Rochester, Minnesota, 55905