Study of Colorectal Cancer Screening Options

NCT05987709 | Completed Results

• 1 other identifier: KPNW Guardant [1866832-1]
• Study Type: interventional
• Target: 2,004
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colon Cancer

Keywords

Colon Cancer Screening

Outcome Measures

Primary Outcomes (1)

• Assess Colorectal Cancer Screening Completion

  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.

  Within 3 months of patient identification

Secondary Outcomes (1)

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

  Within 6 months of abnormal FIT test

Study Arms (2)

Guardant Shield Blood Test

OTHER

Patients will have the Guardant Shield blood test for colorectal cancer screening.

Diagnostic Test: GuardantSHIELD Blood Test

Standard of Care

NO INTERVENTION

Patients will have standard of care, which is a reminder to do their FIT test for colorectal cancer screening

Interventions

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

Guardant Shield Blood Test

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Northwest

Portland, Oregon, 97227, United States

Location

Related Publications (1)

• Coronado GD, Jenkins CL, Shuster E, Johnson C, Amy D, Cook J, Sahnow S, Zepp JM, Mummadi R. Blood-based colorectal cancer screening in an integrated health system: a randomised trial of patient adherence. Gut. 2024 Mar 7;73(4):622-628. doi: 10.1136/gutjnl-2023-330980.

  PMID: 38176899 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Gloria D. Coronado, PhD - Professor, Associate Director Population Sciences, Cancer Center
• Organization: University of Arizona

gdcoronado@arizona.edu

520-626-0023

Study Officials

• Gloria Coronado, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: August 14, 2023
• Study Start: March 17, 2022
• Primary Completion: December 31, 2022
• Study Completion: June 15, 2023
• Last Updated: December 16, 2025
• Results First Posted: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)