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Study of Colorectal Cancer Screening Options

Kaiser Permanente logo

Kaiser Permanente

Status

Completed

Conditions

Colon Cancer

Treatments

Diagnostic Test: GuardantSHIELD Blood Test

Study type

Interventional

Funder types

Other

Identifiers

NCT05987709
KPNW Guardant [1866832-1]

Details and patient eligibility

About

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.

Full description

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.

Enrollment

2,004 patients

Sex

All

Ages

45 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2,004 participants in 2 patient groups

Guardant Shield Blood Test
Other group
Description:
Patients will have the Guardant Shield blood test for colorectal cancer screening.
Treatment:
Diagnostic Test: GuardantSHIELD Blood Test
Standard of Care
No Intervention group
Description:
Patients will have standard of care, which is a reminder to do their FIT test for colorectal cancer screening

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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