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| Name | Class |
|---|---|
| Guardant Health, Inc. | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reminder-Only Group | Experimental | 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. |
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| Reminder + Blood-Based Option Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Complete Colorectal Cancer Screening Within 6 Months | Percentage of participants, between both arms, who complete colorectal cancer screening within 6 months. | Up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Impaired decision-making capability/unable to provide informed consent.
Patients with high-risk conditions:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helen Kattoura | Contact | (305) 243-6438 | hkattoura@miami.edu | |
| Shria Kumar, MD, MSCE | Contact | shriakumar@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Shria Kumar, MD, MSCE | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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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).
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| 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. |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |