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Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold

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ClinicalTrials.gov Identifier: NCT03821948
Recruitment Status : Completed
First Posted : January 30, 2019
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation

Tracking Information
First Submitted Date January 16, 2019
First Posted Date January 30, 2019
Last Update Posted Date July 21, 2020
Actual Study Start Date January 3, 2019
Actual Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 25, 2019)
  • Stool-based biomarkers associated with genetic and epigenetic alterations [ Time Frame: Stool sample will be collected prior to initiation of bowel preparation for colonoscopy. ]
    The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in stool from subjects at average risk or increased risk for development of colorectal cancer at the pre-intervention stage.
  • Blood-based biomarkers associated with genetic and epigenetic alterations. [ Time Frame: Point in time blood collection (1 day) at enrollment. ]
    The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects at average risk or increased risk for development of colorectal cancer at the pre-intervention stage.
Original Primary Outcome Measures Same as current
Change History
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 and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold
Official Title Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold
Brief Summary The primary objective of this study is to collect de-identified, clinically-characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of colorectal cancer (CRC).
Detailed Description Subjects will be men and women, 40 years of age or older who are scheduled for a colonoscopy. Approximately 7,500 subjects will be enrolled.
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 and stool 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 and stool samples will be de-identified.
Sampling Method Non-Probability Sample
Study Population Subjects will be men and women, 40 years of age or older who are scheduled for a colonoscopy. Approximately 7,500 subjects will be enrolled.
Condition Colorectal Cancer
Intervention Not Provided
Study Groups/Cohorts
  • Average CRC Risk Group
    Stool sample collection and blood draw in men and women aged 40 and older with average CRC risk undergoing a standard of care colonoscopy procedure
  • Increased CRC Risk Group
    Stool sample collection and blood draw in men and women aged 40 and older with increased CRC risk undergoing a standard of care colonoscopy procedure
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: May 29, 2020)
5131
Original Estimated Enrollment
 (submitted: January 25, 2019)
3000
Actual Study Completion Date May 15, 2020
Actual Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subject is male or female, 40 years of age or older.
  • Subject is at average or increased risk for development of CRC.
  • Subject presents for screening or surveillance colonoscopy.
  • Subject has no symptoms that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
  • Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria:

  • Any previous cancer diagnosis (with the exceptions of basal cell or squamous cell skin cancers) and/or cancer related treatment (e.g. chemotherapy, immunotherapy, radiation, and/or surgery) within the past 5 years.
  • Subject has a diagnosis or personal history of any of the following conditions, including:

    1. Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome).
    2. Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
    3. Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis and Familial Hyperplastic Polyposis.
  • Subject has a family history of:

    1. Familial adenomatous polyposis (also referred to as "FAP").
    2. Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
  • Subjects with Cronkhite-Canada Syndrome.
  • IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
  • 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 40 Years and older   (Adult, Older 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 NCT03821948
Other Study ID Numbers 2018-08
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: 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 deidentification. This may include text, tables, figures and appendices. The study protocol and informed consent form will also be shared.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Data will be available from 2 years and ending 4 years after publication. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.
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 are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research. Data will available between 2 and 4 years after publication through the Sponsor.
Responsible Party Exact Sciences Corporation
Study Sponsor Exact Sciences Corporation
Collaborators Not Provided
Investigators Not Provided
PRS Account Exact Sciences Corporation
Verification Date July 2020