Trial Outcomes & Findings for An Evaluation of a Multi-target Stool DNA (Mt-sDNA) Test, Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average Risk for Development of Colorectal Cancer: Act Now (NCT NCT03728348)
NCT ID: NCT03728348
Last Updated: 2021-06-04
Results Overview
An optical colonoscopic procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. Results were generated with the use of a logistic-regression algorithm, with values of 183 or more considered to be positive. Tests were processed independently of colonoscopic findings. The test functions as a screening tool by generating a score, based on the detection of hemoglobin and multiple DNA methylation and mutational markers, together with an assessment of the total amount of human DNA in each sample. Specificity =100\*(multi-target stool DNA test negative/negative colonoscopy)
COMPLETED
983 participants
Through study completion, an average of 60 days
2021-06-04
Participant Flow
983 participants provided written informed consent.
Participant milestones
| Measure |
Average Risk Patients
Subjects were men and women 45-49 years of age, inclusive, who were at average risk of developing colorectal cancer. We compared results of a noninvasive, multitarget stool DNA test to colonoscopy. Histopathology was performed on any biopsy or excised lesions.
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|---|---|
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Overall Study
STARTED
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983
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Overall Study
Did Not Complete Study Procedures
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107
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Overall Study
Multi-target DNA Test Excluded
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15
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Overall Study
Colonoscopy Excluded
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19
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Overall Study
COMPLETED
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842
|
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Overall Study
NOT COMPLETED
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141
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Evaluation of a Multi-target Stool DNA (Mt-sDNA) Test, Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average Risk for Development of Colorectal Cancer: Act Now
Baseline characteristics by cohort
| Measure |
Average Risk Patients
n=842 Participants
Subjects were men and women 45-49 years of age, inclusive, who were at average risk of developing colorectal cancer. We compared results of a noninvasive, multi-target stool DNA test to colonoscopy. Histopathology was performed on any biopsy or excised lesions.
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|---|---|
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Region of Enrollment
United States
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842 participants
n=5 Participants
|
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BMI: mean (SD)
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29.6 kg/m^2
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Cigarette Smoking History n(%)
Never Smoked
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582 Participants
n=5 Participants
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|
Cigarette Smoking History n(%)
Former Smoker
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174 Participants
n=5 Participants
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Cigarette Smoking History n(%)
Current Smoker
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86 Participants
n=5 Participants
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Age, Continuous
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47.9 years
STANDARD_DEVIATION 1.5 • n=5 Participants
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Sex: Female, Male
Female
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402 Participants
n=5 Participants
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Sex: Female, Male
Male
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440 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Ethnicity: Hispanic or Latino
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48 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Ethnicity: Not Hispanic or Latino
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794 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race: White
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706 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Race: Black or African American
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95 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Race: Asian
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31 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Race: American Indian or Alaska Native
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race: Native Hawaiian or Other Pacific Islander
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race: Other
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8 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Through study completion, an average of 60 daysPopulation: All completed participants that had a negative colonoscopy.
An optical colonoscopic procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. Results were generated with the use of a logistic-regression algorithm, with values of 183 or more considered to be positive. Tests were processed independently of colonoscopic findings. The test functions as a screening tool by generating a score, based on the detection of hemoglobin and multiple DNA methylation and mutational markers, together with an assessment of the total amount of human DNA in each sample. Specificity =100\*(multi-target stool DNA test negative/negative colonoscopy)
Outcome measures
| Measure |
Multi-target DNA Test Results
n=792 Participants
Subjects were men and women 45-49 years of age, inclusive, who were at average risk of developing colorectal cancer. We compared results of a noninvasive, multitarget stool DNA test to colonoscopy. Histopathology was performed on any biopsy or excised lesions.
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|---|---|
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Specificity of the Multi-target Stool DNA Test in Average Risk Population, Ages 45-49
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95.3 percentage of participants
Interval 93.6 to 96.7
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Adverse Events
Average Risk Patients
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Alexandra Massoud, Sr. Director of Clinical Affairs
Exact Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigator agreed that they shall not, without the Sponsor's prior written consent, independently publish, publicly disclose, present or discuss any results of or information pertaining to the activities conducted under their agreement for a period of one (1) year following completion of the Study.
- Publication restrictions are in place
Restriction type: OTHER