Colorectal Cancer
Conditions
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).
Interventions
BEHAVIORALScreening 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.
PROCEDUREBlood 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.
Sponsors
University of Miami
Guardant Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
This is an interventional study that includes a 1:1 randomization into one of two communication arms: (1) a reminder for colorectal cancer screening, or (2) a reminder for screening that includes standard options and the option for a blood-based screening test, (Shield TM).
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Complete Colorectal Cancer Screening Within 6 Months | Up to 6 months | Percentage of participants, between both arms, who complete colorectal cancer screening within 6 months. |
Countries
United States
Contacts
CONTACTHelen Kattoura
CONTACTShria Kumar, MD, MSCE
PRINCIPAL_INVESTIGATORShria Kumar, MD, MSCE
University of Miami
Outcome results
None listed