Study of Colorectal Cancer Screening Options

Colon Cancer Clinical Trial

Official title:

Study of Colorectal Cancer Screening Options

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05987709
• Other study ID #: KPNW Guardant [1866832-1]
• Status: Completed
• Phase: N/A
• Start date: March 17, 2022
• Est. completion date: June 15, 2023

Study information

• Verified date: June 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 15, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Diagnostic Test:
• GuardantSHIELD Blood 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

Locations

Country	Name	City	State
United States	Kaiser Permanente Northwest	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess colorectal cancer screening completion	Assess the proportion 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.	Within 3 months of patient identification
Secondary	Assess the proportion who completed follow-up testing.	Assess the proportion 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.	Within 6 months of abnormal FIT test