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Guardant Shield Colorectal Cancer Screening

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years to 85 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults who are overdue for colon cancer screening ordered by a University of Miami clinician. It compares a standard reminder by mail or email with the same reminder plus the option of a Shield blood test for screening. Patients are assigned to a group by chance, like a coin flip.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 45 to 85 years old and have an average risk of colon cancer.
  • You can understand the study and agree to take part.
  • You are overdue for a colonoscopy or stool test ordered by your University of Miami clinician. A colonoscopy uses a small camera to look inside your colon.

Who can't join

  • You cannot make an informed decision about joining the study.
  • You have had colon or rectal cancer, adenomas (growths that can turn into cancer), or another cancer.
  • You had a positive colon cancer screening test in the past 6 months, a stool test showing blood in the past 12 months, or an abnormal Cologuard stool test in the past 3 years.
  • You have inflammatory bowel disease, such as ulcerative colitis or Crohn’s disease. These cause long-term swelling in the gut.
  • Your parent, brother, sister, or child has had colon or rectal cancer.
  • You need more frequent screening because of an inherited risk, such as Lynch syndrome, or another listed condition, such as past surgery to remove all or part of your colon.
  • Your doctor ordered a colonoscopy because of symptoms, such as bleeding from your rectum or weight loss, rather than for routine screening.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

FL