Trial Outcomes & Findings for Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer (NCT NCT01397747)
NCT ID: NCT01397747
Last Updated: 2015-12-03
Results Overview
An optical colonoscopic procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The DNA test includes quantitative molecular assays for KRAS mutations, aberrant NDRG4 and BMP3 methylation, and Beta-actin, plus a hemoglobin immunoassay. Results were generated with the use of a logistic-regression algorithm, with values of 183 or more considered to be positive. FIT values of more than 100 ng of hemoglobin per milliliter of buffer were 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. Sensitivity= 100\*(multitarget DNA or FIT positive test/positive colonoscopy); Specificity= 100\*(multitarget DNA or FIT negative test/negative colonoscopy).
COMPLETED
12776 participants
90 Days
2015-12-03
Participant Flow
12,776 participants provided written informed consent. 1,760 could not be evaluated (464- withdrew consent, 1,168- did not undergo colonoscopy, 128- did not submit stool sample).
Participant milestones
| Measure |
Average Risk Patients
Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a noninvasive, multitarget stool DNA test with fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
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|---|---|
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Overall Study
STARTED
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11016
|
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Overall Study
COMPLETED
|
9989
|
|
Overall Study
NOT COMPLETED
|
1027
|
Reasons for withdrawal
| Measure |
Average Risk Patients
Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a noninvasive, multitarget stool DNA test with fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
|
|---|---|
|
Overall Study
Multitarget DNA test excluded
|
689
|
|
Overall Study
Colonoscopy excluded
|
304
|
|
Overall Study
FIT excluded
|
34
|
Baseline Characteristics
Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer
Baseline characteristics by cohort
| Measure |
Average Risk Patients
n=10023 Participants
Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a noninvasive, multitarget stool DNA test with fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
|
|---|---|
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Age, Continuous
|
64.2 years
STANDARD_DEVIATION 8.42 • n=5 Participants
|
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Sex: Female, Male
Female
|
5378 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
4645 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
991 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9028 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
259 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1071 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8422 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
206 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
|
BMI
|
28.83 kg/m^2
STANDARD_DEVIATION 5.836 • n=5 Participants
|
|
Smoking History
Never Smoked
|
5531 participants
n=5 Participants
|
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Smoking History
Former Smoker
|
3589 participants
n=5 Participants
|
|
Smoking History
Current Smoker
|
903 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 DaysAn optical colonoscopic procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The DNA test includes quantitative molecular assays for KRAS mutations, aberrant NDRG4 and BMP3 methylation, and Beta-actin, plus a hemoglobin immunoassay. Results were generated with the use of a logistic-regression algorithm, with values of 183 or more considered to be positive. FIT values of more than 100 ng of hemoglobin per milliliter of buffer were 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. Sensitivity= 100\*(multitarget DNA or FIT positive test/positive colonoscopy); Specificity= 100\*(multitarget DNA or FIT negative test/negative colonoscopy).
Outcome measures
| Measure |
Multitarget DNA Test Results
n=9989 Participants
Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a noninvasive, multitarget stool DNA test in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
|
FIT Test Results
n=9989 Participants
Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
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|---|---|---|
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Sensitivity and Specificity of the Exact CRC Screening Test With Comparison to Colonoscopy, Both With Respect to Cancer.
Sensitivity for any Colorectal Cancer
|
92.3 percent
Interval 83.0 to 97.5
|
73.8 percent
Interval 61.5 to 84.0
|
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Sensitivity and Specificity of the Exact CRC Screening Test With Comparison to Colonoscopy, Both With Respect to Cancer.
Sensitivity Stage I to III
|
93.3 percent
Interval 83.8 to 98.2
|
73.3 percent
Interval 60.3 to 83.9
|
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Sensitivity and Specificity of the Exact CRC Screening Test With Comparison to Colonoscopy, Both With Respect to Cancer.
Sensitivity CRC and HGD
|
83.7 percent
Interval 75.1 to 90.2
|
63.5 percent
Interval 53.5 to 72.7
|
|
Sensitivity and Specificity of the Exact CRC Screening Test With Comparison to Colonoscopy, Both With Respect to Cancer.
Sensitivity Advanced precancerous lesions
|
42.2 percent
Interval 38.9 to 46.0
|
23.8 percent
Interval 20.8 to 27.0
|
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Sensitivity and Specificity of the Exact CRC Screening Test With Comparison to Colonoscopy, Both With Respect to Cancer.
Sensitivity nonadvanced adenoma
|
17.2 percent
Interval 15.9 to 18.6
|
7.6 percent
Interval 6.7 to 8.6
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Sensitivity and Specificity of the Exact CRC Screening Test With Comparison to Colonoscopy, Both With Respect to Cancer.
Specificity nonsignificant findings
|
86.6 percent
Interval 85.9 to 87.2
|
94.9 percent
Interval 94.4 to 95.3
|
|
Sensitivity and Specificity of the Exact CRC Screening Test With Comparison to Colonoscopy, Both With Respect to Cancer.
Specificity negative results colonoscopy
|
89.8 percent
Interval 88.9 to 90.7
|
96.4 percent
Interval 95.8 to 96.9
|
Adverse Events
Average Risk Patients
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