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Trial record 56 of 125 for:    colon cancer AND Rectal | ( Map: New Jersey, United States )

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

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ClinicalTrials.gov Identifier: NCT01397747
Recruitment Status : Completed
First Posted : July 20, 2011
Results First Posted : December 3, 2015
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Conditions Colorectal Neoplasms
Digestive System Diseases
Colonic Diseases
Colorectal Cancer
Enrollment 12776
Recruitment Details  
Pre-assignment Details 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).
Arm/Group Title Average Risk Patients
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 11016
Completed 9989
Not Completed 1027
Reason Not Completed
Multitarget DNA test excluded             689
Colonoscopy excluded             304
FIT excluded             34
Arm/Group Title Average Risk Patients
Hide Arm/Group Description 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 Number of Baseline Participants 10023
Hide Baseline Analysis Population Description
All evaluable participants except for participants who had multitargeted sDNA or colonoscopy excluded.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10023 participants
64.2  (8.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10023 participants
Female
5378
  53.7%
Male
4645
  46.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10023 participants
Hispanic or Latino
991
   9.9%
Not Hispanic or Latino
9028
  90.1%
Unknown or Not Reported
4
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10023 participants
American Indian or Alaska Native
36
   0.4%
Asian
259
   2.6%
Native Hawaiian or Other Pacific Islander
23
   0.2%
Black or African American
1071
  10.7%
White
8422
  84.0%
More than one race
206
   2.1%
Unknown or Not Reported
6
   0.1%
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 10023 participants
28.83  (5.836)
Smoking History  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10023 participants
Never Smoked 5531
Former Smoker 3589
Current Smoker 903
1.Primary Outcome
Title Sensitivity and Specificity of the Exact CRC Screening Test With Comparison to Colonoscopy, Both With Respect to Cancer.
Hide Description 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).
Time Frame 90 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Multitarget DNA Test Results FIT Test Results
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 9989 9989
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent
Sensitivity for any Colorectal Cancer
92.3
(83.0 to 97.5)
73.8
(61.5 to 84.0)
Sensitivity Stage I to III
93.3
(83.8 to 98.2)
73.3
(60.3 to 83.9)
Sensitivity CRC and HGD
83.7
(75.1 to 90.2)
63.5
(53.5 to 72.7)
Sensitivity Advanced precancerous lesions
42.2
(38.9 to 46.0)
23.8
(20.8 to 27.0)
Sensitivity nonadvanced adenoma
17.2
(15.9 to 18.6)
7.6
(6.7 to 8.6)
Specificity nonsignificant findings
86.6
(85.9 to 87.2)
94.9
(94.4 to 95.3)
Specificity negative results colonoscopy
89.8
(88.9 to 90.7)
96.4
(95.8 to 96.9)
Time Frame [Not Specified]
Adverse Event Reporting Description Only device related adverse events were collected.
 
Arm/Group Title Average Risk Patients
Hide Arm/Group Description 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.
All-Cause Mortality
Average Risk Patients
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Average Risk Patients
Affected / at Risk (%)
Total   0/11016 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Average Risk Patients
Affected / at Risk (%)
Total   0/11016 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Operations
Organization: Exact Sciences
Phone: 608-284-5700
EMail: tvaughn@exactsciences.com
Layout table for additonal information
Responsible Party: Exact Sciences Corporation
ClinicalTrials.gov Identifier: NCT01397747     History of Changes
Other Study ID Numbers: Exact Sciences 2011-01
First Submitted: July 18, 2011
First Posted: July 20, 2011
Results First Submitted: December 1, 2015
Results First Posted: December 3, 2015
Last Update Posted: December 3, 2015