Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03728348
Recruitment Status : Completed
First Posted : November 2, 2018
Results First Posted : June 4, 2021
Last Update Posted : June 4, 2021
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Colorectal Cancer
Interventions Diagnostic Test: mt-sDNA screening test
Procedure: Colonoscopy
Enrollment 983
Recruitment Details  
Pre-assignment Details 983 participants provided written informed consent.
Arm/Group Title Average Risk Patients
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 983
Did Not Complete Study Procedures 107
Multi-target DNA Test Excluded 15
Colonoscopy Excluded 19
Completed 842
Not Completed 141
Arm/Group Title Average Risk Patients
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 842
Hide Baseline Analysis Population Description
All evaluable participants except for participants who had mt-sDNA or colonoscopy excluded.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 842 participants
47.9  (1.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 842 participants
Female
402
  47.7%
Male
440
  52.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 842 participants
Ethnicity: Hispanic or Latino
48
   5.7%
Ethnicity: Not Hispanic or Latino
794
  94.3%
Race: White
706
  83.8%
Race: Black or African American
95
  11.3%
Race: Asian
31
   3.7%
Race: American Indian or Alaska Native
1
   0.1%
Race: Native Hawaiian or Other Pacific Islander
1
   0.1%
Race: Other
8
   1.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 842 participants
842
BMI: mean (SD)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 842 participants
29.6  (5.9)
Cigarette Smoking History n(%)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 842 participants
Never Smoked
582
  69.1%
Former Smoker
174
  20.7%
Current Smoker
86
  10.2%
1.Primary Outcome
Title Specificity of the Multi-target Stool DNA Test in Average Risk Population, Ages 45-49
Hide Description 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)
Time Frame Through study completion, an average of 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
All completed participants that had a negative colonoscopy.
Arm/Group Title Multi-target DNA Test Results
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 792
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
95.3
(93.6 to 96.7)
Time Frame Through study completion, an average of 60 days
Adverse Event Reporting Description Only device related adverse events were collected.
 
Arm/Group Title Average Risk Patients
Hide Arm/Group Description 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.
All-Cause Mortality
Average Risk Patients
Affected / at Risk (%)
Total   0/983 (0.00%) 
Hide Serious Adverse Events
Average Risk Patients
Affected / at Risk (%)
Total   0/983 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Average Risk Patients
Affected / at Risk (%)
Total   0/983 (0.00%) 
Subjects with colonoscopic non-advanced adenoma findings were included in the specificity analysis as disease status negative. The colonoscopically 'negative' population included subjects with no findings on colonoscopy and have a higher specificity.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alexandra Massoud, Sr. Director of Clinical Affairs
Organization: Exact Sciences
Phone: 608.284.5700
EMail: clinicaltrials@exactsciences.com
Layout table for additonal information
Responsible Party: Exact Sciences Corporation
ClinicalTrials.gov Identifier: NCT03728348    
Other Study ID Numbers: 2018-10
First Submitted: October 31, 2018
First Posted: November 2, 2018
Results First Submitted: January 20, 2021
Results First Posted: June 4, 2021
Last Update Posted: June 4, 2021