Recruiting

Observational Study

Sponsor:

Exact Sciences Corporation

Code:

NCT06589310

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

Exact Sciences Multicancer Early Detection (MCED) Test

Study Details

Brief summary:

This is a multi-site registry of patients receiving the Exact Sciences Multicancer Early Detection (MCED) test.

Conditions

Cancer

Study ID

NCT06589310

Start date

Aug 1, 2024

Status verified date

May, 2026

Completion date

Jan, 2031

Anticipated

Primary completion date

Aug, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Participant age at time of consent is between 50 and 80 years
  • Agree to receive the Exact Sciences MCED test and follow-up imaging
  • Willing and able to provide informed consent
  • Access to a suitable technology and willing to complete surveys electronically

Exclusion Criteria:

  • Any invasive tumor (excluding non-melanoma skin cancers) or hematological malignancy in the previous three years or current suspicion of cancer and/or in active treatment (e.g., chemotherapy, radiation therapy, immunotherapy, and/or surgery

Study Design

Enrollment

25000 participants

Anticipated

Interventions and Outcome Measures

Arms

Multicancer Early Detection (MCED) cohort

Interventions

Exact Sciences Multicancer Early Detection (MCED) Test

Exact Sciences MCED test, is a qualitative in vitro diagnostic (IVD) for the detection of alterations in circulating tumor DNA and tumor-associated protein levels, which are commonly associated with cancer. It is performed on plasma derived from peripheral blood specimens.

Primary outcome measure

  • Vital status [ Time Frame: Up to 5 years ]
  • Cancer status [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Deb Kettner-Sieber

608-982-6734dkettnersieber@exactsciences.com

Locations

Endeavor Health

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Peter Hulick, M.D.

PHulick@northshore.org

Henry (Mark) Dunnenberger, PharmD

MDunnenberger@northshore.org

Principal Investigator:

Peter Hulick, M.D.

Baylor Scott & White Health

Recruiting

Dallas, Texas, United States, 75246

Contacts

Keisha Riser, MBA

Keisha.Riser@BSWhealth.org

Principal Investigator:

Ronan Kelly, M.D.

More Information

Sponsor

Exact Sciences Corporation

Last update posted

May 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Exact Sciences Corporation on 2026-05-22.