Recruiting

Colonoscopy & ShieldTM

Sponsor:

University of Miami

Code:

NCT07436637

Conditions

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

Screening Reminder

Blood Sample Collection

Study Details

Brief summary:

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).

Conditions

Colorectal Cancer

Study ID

NCT07436637

Start date

Jul 22, 2026

Status verified date

May, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Reminder-Only Group

Participants in this group will receive a standard screening reminder via mailed letter or, if they have an active patient portal account through the University of Miami health (UHealth) portal.

Total participation duration is approximately nine (9) months.

experimental: Reminder + Blood-Based Option Group

Participants in this group will receive a similar reminder, but with the additional option of completing a blood-based screening test (ShieldTM). Communication will be delivered via mailed letter or the UHealth patient portal.

Total participation duration is approximately nine (9) months.

Interventions

Screening Reminder

Participants will receive a standard screening reminder for colorectal cancer screening via mailed letter, or via University of Miami health (UHealth) portal if they have an active active account.

Blood Sample Collection

Participants who consent to the Shield TM by Guardant screening test, will undergo blood sample collection. Approximately 40 mL of blood will be drawn at a UHealth facility into a collection tube provided by Guardant Health.

Primary outcome measure

  • Percentage of Participants Who Complete Colorectal Cancer Screening Within 6 Months [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Helen Kattoura

(305) 243-6438hkattoura@miami.edu

Shria Kumar, MD, MSCE

shriakumar@med.miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Helen Kattoura

(305) 243-6438hkattoura@miami.edu

Shria Kumar, MD, MSCE

shriakumar@med.miami.edu

Principal Investigator:

Shria Kumar, MD, MSCE

More Information

Sponsor

University of Miami

Last update posted

Jul 27, 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 University of Miami on 2026-07-27.