NCT07436637 Guardant Shield Colorectal Cancer Screening
| NCT ID | NCT07436637 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Miami |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2026-07-22 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2026-07-22 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility 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
Contact & Investigator
Shria Kumar, MD, MSCE
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT07436637 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 85 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07436637 currently recruiting?
Yes, NCT07436637 is actively recruiting participants. Contact the research team at hkattoura@miami.edu for enrollment information.
Where is the NCT07436637 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT07436637 clinical trial?
NCT07436637 is sponsored by University of Miami. The principal investigator is Shria Kumar, MD, MSCE at University of Miami. The trial plans to enroll 500 participants.
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