Blood Collection Sub-Study of Exact Sciences Protocol 2018-10: "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"
Conditions: Colo-rectal Cancer
Sponsor: Exact Sciences Corporation

 
2018-10B Protocol Synopsis 
 
Blood Collection Sub-Study of Exact Sciences Protocol 2018-10: “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 Number: NCT03741166 
 
Document Date: October 16th, 2018 

 
 
 
 
1 Protocol Synopsis 2018-10B V 2.0 
 
 
 
 
BLOOD COLLECTION SUB-STUDY OF EXACT 
SCIENCES PROTOCOL 2018-10: “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”  
 
 
 
Study Title:  
Blood Collection Sub-Study of Exact Sciences Protocol 2018-10: “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” 
Study Number:   
2018-10B 
Version and Date:  
Protocol Synopsis Version 2.0, October 16, 2018 
Study Sponsor:  
Exact Sciences 
 
 
 
441 Charmany Drive  
Madison, WI 53719  
 
 
 
 
 
 
 
 
 
 

 
 
 
 
2 Protocol Synopsis 2018-10B V 2.0 
 
1 
PROTOCOL SYNOPSIS 
Primary Objective: 
The primary objective of this sub-study (2018-10B) is to 
collect blood samples for research use in the 
development of the blood-based test for colorectal 
cancer (CRC). 
Study Design: 
Prospective, multi-center, sample collection sub-study 
Population:  
Subjects will be men and women, 45-49 years of age, 
who enroll in Exact Sciences Protocol 2018-10. Up to 
914 subjects will be enrolled.  
Study Duration: 
Duration of subject participation in this sub-study will 
be 1 day from enrollment to completion. 
Study Procedures: 
Subjects providing written informed consent to 
participate in the sub-study will have blood drawn. 
2 
STUDY DESIGN 
This is an optional sub-study, for Exact Sciences Protocol 2018-10, in which blood samples will be 
collected for future investigations of biomarkers for CRC screening.  
Subjects who consent to enroll in Exact Sciences Protocol 2018-10 will be invited to participate in this 
sub-study.  
3 
OBJECTIVES 
3.1 Primary Objective 
The primary objective of this sub-study is to collect blood samples for research use in the development of 
the blood-based test for colorectal cancer. 
4 
Inclusion Criteria  
Subjects must meet the following criteria to be eligible for the study: 
1. Subject is currently enrolled in Exact Sciences Protocol 2018-10. 
2. Subject is willing and able to provide a blood sample. 
3. Subject is willing and able to sign informed consent. 
5 
Exclusion Criteria 
Subjects presenting with any of the following will not be included in the study: 
1. Subject has any condition that in the opinion of the Investigator should preclude participation in 
the study.  
 
 

 
 
 
 
3 Protocol Synopsis 2018-10B V 2.0 
 
APPENDIX 1.0 – STUDY SCHEDULE 
 
Activity 
Enrollment Visit 
Informed Consent  
X 
Obtain Blood Sample  
X 
Adverse Event Reporting  
X