Understanding Patient Preference on Colorectal Cancer Screening Options

NCT05536713 | Completed DMC

• 1 other identifier: IRB22-0345
• Study Type: observational
• Target: 297
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Blood-based screening test order rates

  Number of unique patients who enrolled in the study and received a blood-based screening test order from their providers

  60 days after enrolling in the study

• Blood-based test compliant rates

  Patients who enrolled in the study , received an order for a blood-based screening test, and completed the test

  90 days after received an order for a blood-based screening test

Secondary Outcomes (2)

• Follow-up colonoscopy completion rates

  180 days after received the abnormal blood-based screening test result

• Patient satisfaction with the blood-based test

  30 days after the patient completed the blood-based screening test and received the test result

Study Arms (3)

Federally Qualified Health Center 1

Patients who received an order for colorectal cancer screening, either using a stool-based test or colonoscopy, but failed to complete the screening after six months will be recruited to participate in the study.

Device: Guardant SHIELD blood-based colorectal cancer screening test

Federally Qualified Health Center 2

Patients who received an order for colorectal cancer screening, either using a stool-based test or colonoscopy, but failed to complete the screening after six months will be recruited to participate in the study.

Device: Guardant SHIELD blood-based colorectal cancer screening test

Federally Qualified Health Center 3

Patients who received an order for colorectal cancer screening, either using a stool-based test or colonoscopy, but failed to complete the screening after six months will be recruited to participate in the study.

Device: Guardant SHIELD blood-based colorectal cancer screening test

Interventions

Guardant SHIELD blood-based colorectal cancer screening test DEVICE

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.

Federally Qualified Health Center 1; Federally Qualified Health Center 2; Federally Qualified Health Center 3

Eligibility Criteria

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

Study Population

Patients who are age-eligible for colorectal cancer screening based on the U.S. Preventive Service Task Force recommendation guidelines have an average risk for colorectal cancer.

You may qualify if:

• Between 45-75 years of age
• Have an average risk for colorectal cancer
• A patient at one of our partner FQHCs
• Received a screening order (either using a stool-based test or colonoscopy) six months ago and failed or refused to complete the screening test
• Able to comprehend and willing to give informed consent
• Able and willing to provide a blood sample per protocol

You may not qualify if:

• Family history
• One first-degree relative diagnosed with CRC or advanced adenoma at age \< 60 years
• Two first-degree relatives diagnosed with CRC or advanced adenoma at any age
• Known hereditary gastrointestinal cancer syndromes, such as Lynch Syndrome or Familial Adenomatous and Polyposis (FAP)
• Personal History
• History of CRC or adenoma
• History of cancers
• History of inflammatory bowel disease, including chronic ulcerative colitis and Crohn's disease
• Have a recorded up-to-date CRC screening
• Blood product transfusion in the past 120 days
• A medical condition that, in the opinion of the patient's health provider, should preclude enrollment in the study

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

PCC Community Wellness Center

Chicago, Illinois, 60302, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Karen Kim, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Department of Medicine

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 13, 2022
• Study Start: February 9, 2023
• Primary Completion: December 18, 2025
• Study Completion: December 18, 2025
• Last Updated: February 6, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Within 30 days after the manuscript is published.
• Access Criteria: Users will complete a user agreement.

Locations

US (1)