Clinical Trial TitleClinical Validation of an Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, For Colorectal Cancer Screening BLUE-C
National Clinical Trial Number:NCT0414473
Clinical Trial Protocol Description:
This study is testing an experimental device called Multitarget Stool DNA Based Test (mt-sDNA) 2.0 test. The Exact Sciences’ mt-sDNA 2.0 test is indicated to screen asymptomatic adults for Colorectal Cancer and is under development to enhance clinical performance through product improvements to Cologuard.
The purpose of this study is to determine the ability of the Exact Sciences mt-sDNA 2.0 stool screening test to accurately and reliably detect colorectal cancer and pre-cancer in subjects 40 years and older, when compared with the other standard ways to screen for colorectal cancer, such as with a fecal immunochemical test or a colonoscopy procedure. This is a study to test the performance of the Exact Sciences mt-sDNA 2.0 stool screening test.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are male or female, 40 years of age or older.
- Present for a screening colonoscopy per standard of care.
- Have no symptoms or signs that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
- Understand the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information (PHI) to the study Investigator.
You will be excluded from the study if any of the following criteria apply to you:
- Have a personal history of colorectal cancer (CRC) or advanced precancerous lesions.
- Have a diagnosis or medical / family history of any of the following conditions, including:
- Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner’s syndrome)
- Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome")
- 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, or Familial Hyperplastic Polyposis.
- Have a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn’s disease.
- Have a diagnosis of Cronkhite-Canada Syndrome.
- Have had a positive Cologuard within the previous 2 years, or fecal occult blood test or FIT within the previous 6 months.
- Have undergone a colonoscopy within the previous 9 years, with the exception of a failed colonoscopy due to poor bowel preparation. Failed colonoscopy must have been within the past year and without therapeutic intervention.
- Have had overt rectal bleeding within the previous 30 days.
- Have any condition that in the opinion of the Investigator should preclude participation in the study.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.