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Blood Collection Sub-Study for CRC Screening in Individuals 45-49 at Average Risk for CRC.

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ClinicalTrials.gov Identifier: NCT03741166
Recruitment Status : Completed
First Posted : November 14, 2018
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation

Tracking Information
First Submitted Date October 31, 2018
First Posted Date November 14, 2018
Last Update Posted Date October 8, 2019
Actual Study Start Date November 8, 2018
Actual Primary Completion Date April 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 13, 2018)
Blood-based biomarkers associated with genetic and epigenetic alterations. [ Time Frame: Point in time blood collection (1 day) at enrollment ]
Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects at average risk for development of colorectal cancer.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03741166 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Blood Collection Sub-Study for CRC Screening in Individuals 45-49 at Average Risk for CRC.
Official 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"
Brief Summary The primary objective of this sub-study, 2018-10B, is to collect blood specimens to assess new biomarkers for the detection of Colorectal Cancer (CRC).
Detailed Description Subjects who consent to enroll in Exact Sciences Protocol 2018-10, will be asked to participate in this sub-study. Subjects enrolled in the Exact Sciences Protocol 2018-10, who provide written informed consent to participate in this sub-study, will have a blood sample collected at enrollment.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Residual blood samples may be used for evaluating performance of biomarkers for feasibility and assay development. Sample may be stored for up to 20 years. These blood samples will be de-identified.
Sampling Method Non-Probability Sample
Study Population Subjects will be men and women, 45-49 years of age, who enroll in Exact Sciences Protocol 2018-10. Up to 942 subjects will be enrolled.
Condition Colo-rectal Cancer
Intervention Other: Blood Sample Collection
Subjects participating in the study will have blood drawn at enrollment.
Study Groups/Cohorts Subject aged 45-49 with Average CRC Risk
Subjects will be men and women, 45-49 years of age, who enroll in Exact Sciences Protocol 2018-10. Subjects will provide a blood sample at time of enrollment.
Intervention: Other: Blood Sample Collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 12, 2019)
842
Original Estimated Enrollment
 (submitted: November 13, 2018)
942
Actual Study Completion Date April 5, 2019
Actual Primary Completion Date April 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  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.

Exclusion Criteria:

1. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.

Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years to 49 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03741166
Other Study ID Numbers 2018-10B
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in publications of the study will be shared after de-identification. This may include text, tables, figured, and appendices. The study protocol and informed consent form will also be shared. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Date will be available from 2 years and ending 4 years after publication
Access Criteria: Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research.
Responsible Party Exact Sciences Corporation
Study Sponsor Exact Sciences Corporation
Collaborators Not Provided
Investigators
Principal Investigator: Thomas Imperiale Indiana University
Study Director: Natalia Voge, MD, PhD Exact Sciences
PRS Account Exact Sciences Corporation
Verification Date October 2019