Cancer
Conditions
Brief 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.
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.
Sponsors
Mayo Clinic
National Cancer Institute (NCI)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Has Mayo Clinic medical record number * Has undergone (within last 6 months) or scheduled to undergo a multi-cancer detection test (MCD) as ordered by provider * Able to provide informed consent * ≥ 21 years old * Ability to provide blood sample
Exclusion criteria
* Individuals who have situations that would limit compliance with the study requirements * Institutionalized (i.e. Federal Medical Prison) * Known pregnancy (self-reported) * Currently undergoing active cancer treatment other than adjuvant hormone therapy * Invasive cancer diagnosis within the last 3 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Financial impact of MCD testing | Up to 5 years | 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). |
| Positive actionable MCD results | Up to 5 years | Assessed by the number of participants who receive positive MCD results |
| Psychological Impact of MCD Testing | Baseline (after receiving MCD results) | 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. |
| Change in Patient Satisfaction with MCD Test | Baseline; After receiving MCD results (up to 5 years) | 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). |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
PRINCIPAL_INVESTIGATORJewel Samadder, MD
Mayo Clinic
Outcome results
None listed