Multi-Cancer Detection Observational Cohort Study

Recruiting

• Conditions: Cancer

• Registration Number: NCT06962995
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-30
• Study First Submitted QC: 2025-04-30
• Status Verified: 2025-05
• Study Start: 2025-05-07
• Last Update Submitted: 2025-05-07
• Study First Posted: 2025-05-08
• Last Update Posted: 2025-05-11
• Primary Completion: 2029-06-30
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (3)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States