Multi-Cancer Detection Observational Cohort Study

NCT06962995 | Recruiting

• 2 other identifiers: 24-000321NCI-2025-03276
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (4)

• 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).

  Up to 5 years

• Positive actionable MCD results

  Assessed by the number of participants who receive positive MCD results

  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.

  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).

  Baseline; After receiving MCD results (up to 5 years)

Study Arms (1)

Observational

Patients complete surveys and have their medical records reviewed on study. Patients may undergo blood or buccal swab and urine sample collection on study.

Procedure: Blood Sample; Other: Surveys

Interventions

Blood Sample PROCEDURE

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.

Also known as: Biological Sample Collection, Biospecimen Collection, Specimen Collection, Blood Sample Collection

Observational

Surveys OTHER

Participants will complete surveys related to attitudes and beliefs around Multi-Cancer Detection testing.

Observational

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants who have undergone multi-cancer detection testing (MCD) as part of their clinical care at or outside Mayo Clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Securely stored, de-identified samples and information will be used for future research

MeSH Terms

Conditions

Neoplasms

Interventions

Blood Specimen Collection; Specimen Handling; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jewel Samadder, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 8, 2025
• Study Start: May 7, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)