Trial Outcomes & Findings for Study of Colorectal Cancer Screening Options (NCT NCT05987709)
NCT ID: NCT05987709
Last Updated: 2025-12-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2004 participants
Primary outcome timeframe
Within 3 months of patient identification
Results posted on
2025-12-16
Participant Flow
Participant milestones
| Measure |
Guardant Shield Blood Test
Patients will have the Guardant Shield blood test for colorectal cancer screening.
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
|
Standard of Care
Patients will have standard of care, which is a reminder to do their FIT test for colorectal cancer screening
|
|---|---|---|
|
Overall Study
STARTED
|
1001
|
1003
|
|
Overall Study
COMPLETED
|
1001
|
1003
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Colorectal Cancer Screening Options
Baseline characteristics by cohort
| Measure |
Guardant Shield Blood Test
n=1001 Participants
Patients will have the Guardant Shield blood test for colorectal cancer screening.
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
|
Standard of Care
n=1003 Participants
Patients will have standard of care, which is a reminder to do their FIT test for colorectal cancer screening
|
Total
n=2004 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Hispanic(any race)
|
31 Participants
n=6 Participants
|
35 Participants
n=5 Participants
|
66 Participants
n=5 Participants
|
|
Age, Customized
45-49
|
29 Participants
n=6 Participants
|
28 Participants
n=5 Participants
|
57 Participants
n=5 Participants
|
|
Age, Customized
50-64
|
718 Participants
n=6 Participants
|
722 Participants
n=5 Participants
|
1440 Participants
n=5 Participants
|
|
Age, Customized
65-75
|
254 Participants
n=6 Participants
|
253 Participants
n=5 Participants
|
507 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
642 Participants
n=6 Participants
|
598 Participants
n=5 Participants
|
1240 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
359 Participants
n=6 Participants
|
405 Participants
n=5 Participants
|
764 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
45 Participants
n=6 Participants
|
31 Participants
n=5 Participants
|
76 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
60 Participants
n=6 Participants
|
55 Participants
n=5 Participants
|
115 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/Multiple/Unknown
|
73 Participants
n=6 Participants
|
73 Participants
n=5 Participants
|
146 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
792 Participants
n=6 Participants
|
809 Participants
n=5 Participants
|
1601 Participants
n=5 Participants
|
|
Prior CRC Screening
Prior CRC Screening
|
521 Participants
n=6 Participants
|
520 Participants
n=5 Participants
|
1041 Participants
n=5 Participants
|
|
Prior CRC Screening
No Prior CRC Screening
|
480 Participants
n=6 Participants
|
483 Participants
n=5 Participants
|
963 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 3 months of patient identificationAssess 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.
Outcome measures
| Measure |
Guardant Shield Blood Test
n=1001 Participants
Patients will have the Guardant Shield blood test for colorectal cancer screening.
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
|
Standard of Care
n=1003 Participants
Patients will have standard of care, which is a reminder to do their FIT test for colorectal cancer screening
|
|---|---|---|
|
Assess Colorectal Cancer Screening Completion
|
305 Participants
|
130 Participants
|
SECONDARY outcome
Timeframe: Within 6 months of abnormal FIT testAssess the percentage of participants 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.
Outcome measures
| Measure |
Guardant Shield Blood Test
n=22 Participants
Patients will have the Guardant Shield blood test for colorectal cancer screening.
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
|
Standard of Care
n=10 Participants
Patients will have standard of care, which is a reminder to do their FIT test for colorectal cancer screening
|
|---|---|---|
|
Assess the Percentage of Participants Who Completed Follow-up Testing.
|
11 Participants
|
7 Participants
|
Adverse Events
Guardant Shield Blood Test
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Guardant Shield Blood Test
n=1001 participants at risk
Patients will have the Guardant Shield blood test for colorectal cancer screening.
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
|
Standard of Care
n=1003 participants at risk
Patients will have standard of care, which is a reminder to do their FIT test for colorectal cancer screening
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pain
|
0.10%
1/1001 • Number of events 1 • 9 Months
|
0.00%
0/1003 • 9 Months
|
Additional Information
Gloria D. Coronado, PhD - Professor, Associate Director Population Sciences, Cancer Center
University of Arizona
Phone: 520-626-0023
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place