Trial Outcomes & Findings for Detecting Cancers Earlier Through Elective Plasma-based CancerSEEK Testing (NCT NCT04213326)
NCT ID: NCT04213326
Last Updated: 2024-06-14
Results Overview
The primary objective of the study is to collect blood samples from known cancer and non cancer participants. These blood samples were used to calibrate the CancerSEEK assay. There was no pre-defined performance threshold.
Recruitment status
COMPLETED
Target enrollment
6400 participants
Primary outcome timeframe
6 months
Results posted on
2024-06-14
Participant Flow
Participant milestones
| Measure |
Cancer Cohort
Subjects interested in the cancer cohort, will sign an informed consent, complete an optional survey, and have 60mLs of blood draw by a licensed phlebotomist.
|
Non-Cancer Cohort
Subjects interested in the non-cancer cohort, will sign an informed consent, complete an optional survey, and have 60mLs of blood draw by a licensed phlebotomist.
|
|---|---|---|
|
Overall Study
STARTED
|
937
|
5463
|
|
Overall Study
COMPLETED
|
727
|
3893
|
|
Overall Study
NOT COMPLETED
|
210
|
1570
|
Reasons for withdrawal
| Measure |
Cancer Cohort
Subjects interested in the cancer cohort, will sign an informed consent, complete an optional survey, and have 60mLs of blood draw by a licensed phlebotomist.
|
Non-Cancer Cohort
Subjects interested in the non-cancer cohort, will sign an informed consent, complete an optional survey, and have 60mLs of blood draw by a licensed phlebotomist.
|
|---|---|---|
|
Overall Study
Consent withdrawn
|
51
|
241
|
|
Overall Study
Lost to Follow-up
|
50
|
902
|
|
Overall Study
Protocol Violation
|
3
|
25
|
|
Overall Study
Participant eligibility changed
|
106
|
19
|
|
Overall Study
SCRI confirmed to be withdrawal
|
0
|
16
|
|
Overall Study
Incomplete study visit
|
0
|
367
|
Baseline Characteristics
The numbers analyzed in the sex category differ from the overall participants due to missing data for 26 subjects. Sex was not able to be collected for 19 subjects in the cancer cohort and 7 in the non-cancer cohort.
Baseline characteristics by cohort
| Measure |
Cancer Cohort
n=727 Participants
Subjects interested in the cancer cohort, will sign an informed consent, complete an optional survey, and have 60mLs of blood draw by a licensed phlebotomist.
|
Non-Cancer Cohort
n=3893 Participants
Subjects interested in the non-cancer cohort, will sign an informed consent, complete an optional survey, and have 60mLs of blood draw by a licensed phlebotomist.
|
Total
n=4620 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 9 • n=727 Participants
|
62 years
STANDARD_DEVIATION 8 • n=3893 Participants
|
62 years
STANDARD_DEVIATION 8 • n=4620 Participants
|
|
Sex: Female, Male
Female
|
451 Participants
n=708 Participants • The numbers analyzed in the sex category differ from the overall participants due to missing data for 26 subjects. Sex was not able to be collected for 19 subjects in the cancer cohort and 7 in the non-cancer cohort.
|
2374 Participants
n=3886 Participants • The numbers analyzed in the sex category differ from the overall participants due to missing data for 26 subjects. Sex was not able to be collected for 19 subjects in the cancer cohort and 7 in the non-cancer cohort.
|
2825 Participants
n=4594 Participants • The numbers analyzed in the sex category differ from the overall participants due to missing data for 26 subjects. Sex was not able to be collected for 19 subjects in the cancer cohort and 7 in the non-cancer cohort.
|
|
Sex: Female, Male
Male
|
257 Participants
n=708 Participants • The numbers analyzed in the sex category differ from the overall participants due to missing data for 26 subjects. Sex was not able to be collected for 19 subjects in the cancer cohort and 7 in the non-cancer cohort.
|
1512 Participants
n=3886 Participants • The numbers analyzed in the sex category differ from the overall participants due to missing data for 26 subjects. Sex was not able to be collected for 19 subjects in the cancer cohort and 7 in the non-cancer cohort.
|
1769 Participants
n=4594 Participants • The numbers analyzed in the sex category differ from the overall participants due to missing data for 26 subjects. Sex was not able to be collected for 19 subjects in the cancer cohort and 7 in the non-cancer cohort.
|
|
Race/Ethnicity, Customized
Race · White
|
525 Participants
n=727 Participants
|
3360 Participants
n=3893 Participants
|
3885 Participants
n=4620 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
83 Participants
n=727 Participants
|
316 Participants
n=3893 Participants
|
399 Participants
n=4620 Participants
|
|
Race/Ethnicity, Customized
Race · Asian/Pacific Islander
|
3 Participants
n=727 Participants
|
53 Participants
n=3893 Participants
|
56 Participants
n=4620 Participants
|
|
Race/Ethnicity, Customized
Race · Native American/Alaskan
|
1 Participants
n=727 Participants
|
14 Participants
n=3893 Participants
|
15 Participants
n=4620 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
11 Participants
n=727 Participants
|
65 Participants
n=3893 Participants
|
76 Participants
n=4620 Participants
|
|
Race/Ethnicity, Customized
Race · Missing
|
104 Participants
n=727 Participants
|
85 Participants
n=3893 Participants
|
189 Participants
n=4620 Participants
|
|
Region of Enrollment
United States
|
727 participants
n=727 Participants
|
3893 participants
n=3893 Participants
|
4620 participants
n=4620 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Blood samples collected to be used to calibrate the CancerSEEK assay.
The primary objective of the study is to collect blood samples from known cancer and non cancer participants. These blood samples were used to calibrate the CancerSEEK assay. There was no pre-defined performance threshold.
Outcome measures
| Measure |
Cancer Cohort
n=727 Participants
Subjects interested in the cancer cohort, will sign an informed consent, complete an optional survey, and have 60mLs of blood draw by a licensed phlebotomist.
|
Non-Cancer Cohort
n=3893 Participants
Subjects interested in the non-cancer cohort, will sign an informed consent, complete an optional survey, and have 60mLs of blood draw by a licensed phlebotomist.
|
|---|---|---|
|
Study Data and Samples Were Used for CancerSEEK Assay Development
Not withdrawn, With Blood Draw
|
712 Participants
|
3870 Participants
|
|
Study Data and Samples Were Used for CancerSEEK Assay Development
Withdrawn, With Blood Draw (lost to follow up)
|
5 Participants
|
14 Participants
|
|
Study Data and Samples Were Used for CancerSEEK Assay Development
Withdrawn after Blood Draw
|
10 Participants
|
9 Participants
|
Adverse Events
Cancer Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Cancer Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place