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Recruiting

NCT Number: NCT07436637

Guardant Shield Colorectal Cancer Screening

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).

Recruiting

Interested in participating?

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Austin R Dosch, MD, PhD

PRINCIPAL_INVESTIGATOR

Helen Kattoura

CONTACT

[email protected]

(305) 243-6438

Shria Kumar, MD, MSCE

CONTACT

[email protected]

Shria Kumar, MD, MSCE

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Screening Reminder

Behavioral

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

Procedure

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 outcomes

  1. Percentage of Participants Who Complete Colorectal Cancer Screening Within 6 Months

    Time frame: Up to 6 months

    Percentage of participants, between both arms, who complete colorectal cancer screening within 6 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Helen Kattoura

CONTACT

[email protected]

(305) 243-6438

Shria Kumar, MD, MSCE

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Guardant Health, Inc.

Registry information

Official study title

Using Guardant ShieldTM to Facilitate Colorectal Cancer Screening in Under-screened Individuals in a Diverse Patient Population

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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