Clinical trial · Interventional
Guardant Shield Colorectal Cancer Screening
Using Guardant ShieldTM to Facilitate Colorectal Cancer Screening in Under-screened Individuals in a Diverse Patient Population
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Sample Collection | Procedure | — | UNRESOLVED |
| Screening Reminder | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Reminder-Only Group
- description
- 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.
- interventionNames
- Behavioral: Screening Reminder
- type
- EXPERIMENTAL
- label
- Reminder + Blood-Based Option Group
- description
- 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.
- interventionNames
- Behavioral: Screening Reminder
- Procedure: Blood Sample Collection
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available