Colorectal Cancer Screening, Colorectal Cancer
Conditions
Keywords
colorectal cancer, Colorectal cancer screening
Brief summary
This is a prospective longitudinal study to assess the impact of repeat Cologuard testing at 3 years in average risk patients.
Detailed description
This is a prospective longitudinal study to assess the impact of repeat Cologuard testing at 3 years in average risk patients. Enrolled subjects will be prescribed Cologuard per approved labeling at baseline. Subjects with positive results will be referred to colonoscopy and study participation completed. Subjects with negative Cologuard results will be seen annually for 3 years. At year 3, subjects will repeat Cologuard, followed by colonoscopy, regardless of the Cologuard test outcome. Subjects who have a colonoscopy at any time during the study will be discontinued following collection of the colonoscopy and associated histopathology results.
Interventions
DEVICECologuard
Prescription of Cologuard for at-home stool collection
Sponsors
Exact Sciences Corporation
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subject has been prescribed Cologuard for colorectal cancer screening 2. Subject is at average risk for development of colorectal cancer 3. Subject is 50 years or older 4. Subject willing and able to sign informed consent.
Exclusion criteria
1. Subject had a colonoscopy in the previous 9 years 2. Subject has undergone any double-contrast barium enema, virtual (CT-based) colonoscopy, or flexible sigmoidoscopy within the previous five (5) years. 3. Subject has had a positive fecal occult blood test or FIT within the previous six (6) months. 4. Subject has any condition that in the opinion of the investigator should preclude participation in the study (e.g., subject not eligible for a diagnostic colonoscopy). 5. Subject has a history of colorectal cancer or advanced adenoma. 6. Subject has a history of aerodigestive tract cancer 7. Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease 8. Subject has had overt rectal bleeding, e.g. hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding) 9. Subject has a diagnosis or personal history of any of the following high-risk conditions for colorectal cancer: * Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease. * 2 first-degree relatives who have been diagnosed with colon cancer. (Note: first-degree relatives include parents, siblings and offspring). * One first-degree relative with CRC diagnosed before the age of 60. 10. Subject has a family history of: * Familial adenomatous polyposis (also referred to as FAP, including attenuated FAP). * Hereditary non-polyposis colorectal cancer 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), Gardner's Syndrome, Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Predictive Value | Three years | The difference between the positive predictive value (PPV) at year 3 (PPV3) and 1 minus the negative predictive value (NPV) at year 3 (NPV3). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Colorectal Cancer Incidence | 3 years | Observed versus the expected reduction in colorectal cancer incidence at year 3 (T3) |
Other
| Measure | Time frame | Description |
|---|---|---|
| The predicative value of a positive and a negative Cologuard at year 3 (T3). | 3 years | The predicative value of a positive and a negative Cologuard at year 3 (T3). |
| The sensitivity and specificity of Cologuard at year 3 (T3). | 3 years | The sensitivity and specificity of Cologuard at year 3 (T3). |
| The positive (PLR) and negative (NLR) likelihood ratios at year 3 (T3). | 3 years | The positive (PLR) and negative (NLR) likelihood ratios at year 3 (T3). |
| The cumulative risk of false positive result (cFPR) and cumulative risk of a true positive result (cTPR). | 3 years | The cumulative risk of false positive result (cFPR) and cumulative risk of a true positive result (cTPR). |
| The probability that a negative Cologuard result at baseline remains negative through 3 years. | 3 years | The probability that a negative Cologuard result at baseline remains negative through 3 years. |
| Adherence to repeat Cologuard at year 3 (T3) | 3 years | Adherence to repeat Cologuard at T3 will be reported with counts and proportions. |
| The distribution of colorectal epithelial lesions (by Category) among positive Cologuard subjects at T0 and at T3 | 3 years | The distribution of colorectal epithelial lesions (by Category) among positive Cologuard subjects at T0 and at T3 |
| Compliance to colonoscopy following a positive Cologuard result | baseline | Cumulative compliance to colonoscopy following a positive Cologuard result |
| Cross-over to alternative screening methodologies (e.g. FOBT, colonoscopy, other) at T1,T2, and T3 | Years 1, 2, and 3 | Cross-over to alternative screening methodologies (e.g. FOBT, colonoscopy, other) at T1,T2, and T3 |
| The rate of no Cologuard result (e.g. invalid result) | 3 years | The rate of no Cologuard result (e.g. invalid result) |
| The adverse event rate (events occurring between collection kit distribution and sample submission) | 3 years | The adverse event rate (events occurring between collection kit distribution and sample submission) |
| The probability that a negative Cologuard result at baseline (T0) results in no CRC/AA through 3 years. | 3 years | The probability that a negative Cologuard result at baseline (T0) results in no CRC/AA through 3 years. |
| Predictive value of a positive Cologuard result at baseline (T0) | baseline | Predictive value of a positive Cologuard result at baseline (T0) |
Countries
United States
Outcome results
None listed