Understanding Patient Preference on Colorectal Cancer Screening Options

Summary

Early detection by screening significantly reduces mortality from colorectal cancer (CRC). However, CRC screening rates have plateaued, with a considerable segment of the population remaining unscreened. Not being up to date with screening was associated with an approximate 3-fold risk for CRC-related mortality. There are different well-established CRC screening modalities, including invasive and non-invasive, which detect both polyps and cancer or cancer alone. Colonoscopy remains the dominant screening modality in the U.S.; however, colonoscopy uptake is low due to the invasiveness, perception of discomfort and embarrassment, logistical challenges, cost, and potential risks.

Increasing patient compliance and adherence to screening is critical to improving CRC outcomes. A key to enhancing screening participation is patient acceptance of the testing method. A blood-based screening test presents an opportunity to overcome some challenging barriers. Blood-based tests are non-invasive compared to colonoscopy and can easily be part of a standard medical office appointment for a wellness check or scheduled visits to manage chronic illnesses and be completed at the point of care. This study will examine patient preference to use a blood-based screening test and compliance with CRC screening recommendations after failing to complete the FIT (Fecal Immunochemical Test)/FOBT (Fecal Occult Blood Test) or colonoscopy order in six months. Compliance with CRC screening is particularly poor among medically underserved populations, and most of these vulnerable individuals use federally qualified health centers (FQHCs) to obtain care. Implementing a blood-based screening test at FQHCs has the potential to improve CRC screening uptake and adherence and improve health disparities in medically underserved populations.

This study seeks to answer the following four questions: 1) What is the acceptability of a blood-based screening as an alternative for patients who failed to complete a prior order using traditional screening methods? 2) Are patients who failed to comply with traditional screening methods more likely to comply with a blood-based screening test? 3) What is the effect of offering a blood-based screening test for patients who are non-compliance with traditional screening methods on overall CRC screening rates? 4) What are the facilitators and barriers to implementing the blood-based screening test in clinical settings?

Conditions

• Colorectal Cancer

Interventions

DEVICE

Guardant SHIELD blood-based colorectal cancer screening test

The Guardant SHIELD test combines a next-generation sequencing (NGS) based assay and a protein assay for the qualitative detection of colorectal cancer-derived tumor signal in the blood of patients at average risk for CRC. The Guardant SHIELD was developed at Guardant Health's clinical laboratory, a certified laboratory under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), to perform high-complexity clinical laboratory testing. The test has not been cleared or approved by the U.S. Food and Drug Administration (FDA); however, its performance has been established through a clinical trial, the ECLIPSE study (ClinicalTrials.gov Identifier: NCT04136002). The ECLIPSE clinical trial was a prospective, multi-site registration study and reached the targeted enrollment of 12,750 patients in December 2021.

Sponsors & Collaborators

• Milton S. Hershey Medical Center

  lead OTHER

Principal Investigators

• Karen Kim, MD · University of Chicago

Eligibility

Min Age

45 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-02-09

Primary Completion

2025-12-18

Completion

2025-12-18

Countries

• United States

Study Locations