Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer (DeeP-C)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation
ClinicalTrials.gov Identifier:
NCT01397747
First received: July 18, 2011
Last updated: December 1, 2015
Last verified: November 2015
Results First Received: December 1, 2015  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: Colorectal Neoplasms
Digestive System Diseases
Colonic Diseases
Colorectal Cancer

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Average Risk Patients  
STARTED     11016  
COMPLETED     9989  
NOT COMPLETED     1027  
Multitarget DNA test excluded                 689  
Colonoscopy excluded                 304  
FIT excluded                 34  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All evaluable participants except for participants who had multitargeted sDNA or colonoscopy excluded.

Reporting Groups
  Description
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.

Baseline Measures
    Average Risk Patients  
Number of Participants  
[units: participants]
  10023  
Age  
[units: years]
Mean (Standard Deviation)
  64.2  (8.42)  
Gender  
[units: participants]
 
Female     5378  
Male     4645  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     991  
Not Hispanic or Latino     9028  
Unknown or Not Reported     4  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     36  
Asian     259  
Native Hawaiian or Other Pacific Islander     23  
Black or African American     1071  
White     8422  
More than one race     206  
Unknown or Not Reported     6  
BMI  
[units: kg/m^2]
Mean (Standard Deviation)
  28.83  (5.836)  
Smoking History  
[units: participants]
 
Never Smoked     5531  
Former Smoker     3589  
Current Smoker     903  



  Outcome Measures

1.  Primary:   Sensitivity and Specificity of the Exact CRC Screening Test With Comparison to Colonoscopy, Both With Respect to Cancer.   [ Time Frame: 90 Days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Director of Clinical Operations
Organization: Exact Sciences
phone: 608-284-5700
e-mail: tvaughn@exactsciences.com


Publications of Results:

Responsible Party: Exact Sciences Corporation
ClinicalTrials.gov Identifier: NCT01397747     History of Changes
Other Study ID Numbers: Exact Sciences 2011-01
Study First Received: July 18, 2011
Results First Received: December 1, 2015
Last Updated: December 1, 2015
Health Authority: United States: Food and Drug Administration