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Guardant Shield Colorectal Cancer Screening

University of Miami · with Guardant Health, Inc. · NCT07436637

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 45–85 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
500
US sites recruiting
1
Study start
July 22, 2026
Record last updated
October 16, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The purpose of this research is to identify individuals overdue for colon cancer screening and send them a reminder to complete their screening, which includes standard of care colonoscopy or stool-based testing. The investigators are randomizing patients (like a flip of a coin) to either receive the standard reminder by mail/email or to receive the standard reminder and have the option to provide a blood sample for screening (ShieldTM by Guardant).

Being studied: Screening Reminder; Blood Sample Collection

Conditions: Colorectal Cancer

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Adults 45 - 85 years of age at average risk and able to provide informed consent.
  • Patients overdue for a screening colonoscopy or stool-based test that was ordered by their University of Miami (UM) clinician.

Exclusion Criteria

  • Impaired decision-making capability/unable to provide informed consent.
  • Patients with high-risk conditions:
  • Personal history of colorectal cancer (CRC), adenomas, or other cancers
  • Those who had a positive result on another CRC screening method within the last six months, an abnormal stool test that found blood in your stool within the last 12 months, or abnormal Cologuard (FIT-DNA Test) in the last 3 years
  • Those with Inflammatory Bowel Disease (IBD), chronic ulcerative colitis (CUC), Crohn's disease
  • Those who have a family history of colorectal cancer (in a parent, brother, sister, or child)
  • Genetic predisposition requiring more frequent screening (such as Lynch syndrome, IBD, history of colectomy, etc.)
  • Symptoms like rectal bleeding, weight loss, or other signs for which your doctor ordered a colonoscopy - not simply as a screening tool

Recruiting US locations

  • University of Miami

    Miami, FL 33136

    Site contact: Helen Kattoura · (305) 243-6438 · hkattoura@miami.edu

Study contacts (from the official record)

  • Helen Kattoura · (305) 243-6438 · hkattoura@miami.edu
  • David S Goldberg, MD · +1 (305) 2437956 · dsgoldberg@med.miami.edu
All healthy volunteers studies in Florida →
Guardant Shield Colorectal Cancer Screening (NCT07436637) | Bored Studies