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Study for individuals who have a Scheduled Screening Colonoscopy

Exact Sciences has developed a screening test that is designed to detect colorectal cancer (CRC) and pre-cancer in stool. The test is called Cologuard, a multi-target stool DNA test, and was approved by the FDA, for use in patients 45 years or older who are at average risk for colorectal cancer. The purpose of this study is to learn more about the effectiveness of an improved at-home stool screening test and its ability to accurately and reliably detect colorectal cancer and pre-cancer in people who are 40 years and older when compared with the other standard ways to screen for colorectal cancer, (an immunochemical test or a colonoscopy). By understanding the performance of this test, it will help us improve screening access and convenience.

Age & Gender

  • 55 years ~ 99 years
  • Male, Female

Visit Availability

  • Standard business hours (M-F, 8-5)
  • Extended hours (M-F, early morning or evening)
  • Visits can be combined with regular clinical appointments

Location

North Carolina (Orange)

What will be asked of you

Study staff will ask you questions about your health (including past and present diseases and colonoscopy procedures) to determine if you are eligible to participate. If you are eligible, we will get some information from you about your medical history, and family history. You will be provided a stool collection kit: mt-sDNA 2.0 test and the commercially-available test called FIT, along with instructions for at home stool collection and shipment. You will also be given information about an optional sub-study that requires a blood draw.

Incentives

Up to $575

In-person visits:
1
Total length of participation:
Approximately 90 days

Looking for Healthy Volunteers

Requirements for healthy volunteers are different than for those with a specific condition. If you are interested in becoming a healthy volunteer for this study, use the below categories to determine if you are able to participate.

Able to participate:

  • You are scheduled for a screening colonoscopy at a UNC Healthcare location
  • You are 55 years or older
  • This is your first screening colonoscopy

Not eligible if:

  • You have a personal history of Colorectal cancer or advanced precancerous lesions
  • Have undergone a colonoscopy within the last 9 years
  • Have a medical history of IBD, chronic ulcerative colitis, and/or Crohn's Disease
  • Have had a positive Cologuard in the last 2 years

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

Clinical and Translational Research Center (CTRC)
Burnett-Womack Building (UNC-Chapel Hill)
160 Dental Cir, Chapel Hill, NC 27514, USA

Secondary Contact

Secondary Visit Location

GI Clinic
REX Digestive Healthcare
2417 Atrium Dr, Raleigh, NC 27607, USA

Additional Study Information

Principal Investigator

Sarah McGill
Medicine-Gastroenterology

Study Type

Clinical or Medical
Observational

Study Topics

Cancer (Colorectal)
Stomach, Digestion and Gut Health
Healthy Volunteer or General Population
UNC or UNC Health employees

IRB Number

19-3475

ClinicalTrials.gov

NCT04144738 and NCT04144751

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Copyright © 2013-2022 The NC TraCS Institute, the integrated home of the NIH Clinical and Translational Science Awards (CTSA) Program at UNC-CH.  This website is made possible by CTSA Grant UL1TR002489 and the National Center for Advancing Translational Sciences.

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