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OpenTrials
Completed

NCT Number: NCT05987709

Study of Colorectal Cancer Screening Options

The investigators propose to evaluate Guardant Health's commercially available colorectal cancer screening assay(Guardant SHIELD) in individuals who are not up to date with CRC screening.

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Northwest

Portland, Oregon, 97227, United States

About this study

The investigators propose to evaluate Guardant Health's commercially available colorectal cancer screening assay(Guardant SHIELD) in individuals who are not up to date with CRC screening.

Primary Objective (or Aim) Assess colorectal cancer screening completion among patients who are non-adherent after receiving stool test outreach, who have an upcoming clinical appointment, and who are offered a commercially available colorectal cancer blood test versus usual care (i.e. reminder to complete stool testing during their clinical appointment).

Secondary Objectives (or Aim) Assess patients' and providers' perceived confidence in the test (based on available test performance characteristics) and willingness to obtain/offer the test on an on-going basis, based on qualitative interviews; assess preliminary rates of follow-up colonoscopy completion (after an initial abnormal test result) among participants allocated to the blood test vs. usual care condition.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 45-75
  • Received a FIT test in the last 3-9 months yet did not return their FIT
  • Upcoming appointment or willing to reschedule an appointment at KPNW within 2 - 6 weeks
  • Able and willing to provide informed consent if in the intervention arm

Exclusion criteria

  • On KPNW's do not contact list
  • Having a legal authorized representative
  • Non-English speakers

Treatment and study plan

GuardantSHIELD Blood Test

Diagnostic Test

The GuardantSHIELD CRC screening test is a commercially available test which works by finding signs of colorectal tumor in the blood of patients at average risk for CRC

Primary outcomes

  1. Assess Colorectal Cancer Screening Completion

    Time frame: Within 3 months of patient identification

    Assess the percentage who received any CRC screening test (blood draw, FIT or FIT-DNA, or flexible sigmoidoscopy or colonoscopy) within 3 months of eligibility determination among eligible individuals in the blood test and usual care groups.

Secondary outcomes

  1. Assess the Percentage of Participants Who Completed Follow-up Testing.

    Time frame: Within 6 months of abnormal FIT test

    Assess the percentage of participants who completed follow-up colonoscopy within 6 months of their result among individuals with an abnormal non-invasive test result; comparing the blood test and usual care groups.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 14, 2023
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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