Status:
TERMINATED
Informed Choice - Compass
Lead Sponsor:
Exact Sciences Corporation
Collaborating Sponsors:
Mayo Clinic
University of Utah
Conditions:
Colorectal Cancer
Eligibility:
All Genders
45-70 years
Brief Summary
The primary objective of this study is to evaluate the impact of a theoretically grounded video that includes information about CRC screening modality choices on CRC screening rates and time adherent ...
Detailed Description
Participants 45 to 70 years of age, scheduled for a primary care (index) appointment, at average risk for colorectal cancer (CRC), and due for CRC screening will be enrolled in the study. Participants...
Eligibility Criteria
Inclusion
- Participant is 45 to 70 years of age, inclusive.
- Participant presents for a primary care appointment.
- Participant understands 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.
- Participant has never been screened for CRC.
Exclusion
- Participant has symptoms or signs that require immediate, or near-term referral for diagnostic or therapeutic colonoscopy.
- Participant is due for CRC screening within three months and is already scheduled for colonoscopy.
- Participant has a personal history of CRC or colonic adenomatous or sessile serrated polyps.
- Participant has a personal history of inflammatory bowel disease.
- Participant has a family history of CRC in at least one first- or second-degree relative diagnosed prior to age 60 and/or at least 2 first-degree relatives diagnosed with CRC at any age.
- Participant has a personal diagnosis or family history of any of the following conditions:
- 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.
- Participant has a diagnosis of Cronkhite-Canada Syndrome.
- Participant is current with CRC screening, including gFOBT or FIT within the preceding 12 months, Cologuard within the preceding 3 years, flexible sigmoidoscopy or CT colonography within the preceding 5 years, or colonoscopy within the preceding 10 years. Participants can be enrolled up to 3 months prior to screening due date.
- Participant has any condition that in the opinion of the Investigators should preclude participation in the study, including comorbid illnesses precluding endoscopic evaluation or that limit life expectancy to less than 10 years.
Key Trial Info
Start Date :
April 28 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
1823 Patients enrolled
Trial Details
Trial ID
NCT05246839
Start Date
April 28 2022
End Date
January 31 2025
Last Update
November 7 2025
Active Locations (39)
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1
Absolute Clinical Research
Phoenix, Arizona, United States, 85323
2
Biopharma Informatic
Los Angeles, California, United States, 90035
3
Saviers Medical Group
Port Hueneme, California, United States, 93041
4
Skylight Health Group
Aurora, Colorado, United States, 80012