Trial results for a study evaluating colorectal cancer screening options were posted on ClinicalTrials.gov on 2025-12-16, indicating that 305 participants completed screening using the Guardant Shield Blood Test compared to 130 with standard of care.
Background
Colorectal cancer (CRC) is a significant public health concern, and early detection through screening is crucial for improving patient outcomes. Despite the availability of various screening methods, many individuals remain unscreened or are not up to date with recommended guidelines. This gap in screening adherence contributes to later-stage diagnoses and poorer prognoses. Therefore, exploring alternative or more accessible screening options, such as blood-based tests, is important to increase screening completion rates, especially among populations who may face barriers to traditional methods.
Trial design
This completed study, identified as Phase NA, enrolled 2004 participants with Colon Cancer. The trial aimed to evaluate Guardant Health's commercially available colorectal cancer screening assay (Guardant SHIELD) in individuals not up to date with CRC screening. The study compared screening completion rates between participants offered the Guardant Shield Blood Test and those offered Standard of Care. Key outcomes assessed included the completion of colorectal cancer screening and the percentage of participants who completed follow-up testing.
Key results
The trial results provide insights into colorectal cancer screening completion and follow-up testing:
- For the outcome "Assess Colorectal Cancer Screening Completion," 305 participants in the Guardant Shield Blood Test group completed screening, compared to 130 participants in the Standard of Care group.
- For the outcome "Assess the Percentage of Participants Who Completed Follow-up Testing," 11 participants in the Guardant Shield Blood Test group completed follow-up testing, while 7 participants in the Standard of Care group completed follow-up testing.
What this means
The posted trial results suggest that offering the Guardant Shield Blood Test as a screening option may lead to higher rates of colorectal cancer screening completion compared to standard of care. With 305 participants completing screening in the Guardant Shield group versus 130 in the standard of care group, the blood test appears to be a more accessible or preferred option for individuals not up to date with screening. While the number of participants completing follow-up testing was lower overall (11 for Guardant Shield vs. 7 for standard of care), the relative difference in initial screening completion is notable. These findings indicate a potential benefit for incorporating blood-based screening assays like Guardant Shield to improve overall colorectal cancer screening adherence, particularly in populations that are currently underscreened.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05987709, titled "Study of Colorectal Cancer Screening Options", were posted on 2025-12-16 on clinicaltrials.gov.