NEJM
What is the exact FIT test used in the study?
OC Polymedco Fit Check
Primary Objective?
How many previously non-compliant average-risk Medicare patients would complete a doctor-ordered Cologuard screening within 1 year?
How many estimated CRC related deaths were there in 2019 vs 2020?
2019 - 51,000
2020- 53,000
Primary Objective?
To measure the impact that knowledge of a positive mt-sDNA test (Cologuard) has on colonoscopy yield and quality
CRC is ranked number __ in leading cause of cancer deaths among men and women in the US
#2
What is the study's design?
- blinded
- point in time
- prospective
- head to head
- 90 sites (1 in Canada)
Secondary Objective?
What percentage of patients who received a positive CG result would complete a diagnostic colonoscopy?
5 year relative survival rate in early stage vs late stage CRC
early stage (I-II): 90%
late stage (IV): 14%
Briefly describe the study design
compared findings and withdrawal times between 2 groups of patients (unblinded cohort that received positive CG result vs blinded cohort used from NEJM trial)
__ out of 5 people diagnosed with CRC have no family history
4 out of 5
What are the 4 categories that Cologuard outperformed FIT in at the detection of CRC? (Figure 2)
Stage, Location, Type, and Size
How many people participated in the study?
393
Oncologists surveyed reported a __% decline in cancer diagnoses due to Covid
57%
What is the ratio in the median number of polyps detected between the unblinded and blinded cohorts?
2 and 1 (unblinded vs blinded respectively)
When was Exact Sciences founded?
1995
What are the primary and secondary outcomes of the study?
What percentage of adults aged 50-54 years reported recent screening for CRC?
45%
1) differences in pts screened in routine practice vs those in clinical trial
2) withdrawal time is considered a surrogate marker
3) two comparison groups separated in time - likely differences in colonoscopy practice
4) not all pts who tested positive for CG completed the diagnostic colonoscopy
What are 5 ways to screen for CRC?
- Cologuard (of course)
- Colonoscopy
- FIT/FOBT
- flexible sigmoidoscopy
- CT colonography
What is Cologuard and FIT's sensitivity at detecting CRC AND Advanced Adenomas?
CRC: Cologuard-92% | FIT-74%
Advanced Adenomas: Cologuard-42% | FIT-24%
Secondary Objective outcome?
96.1% of those were compliant with a diagnostic colonoscopy (49/51)
FIT failed to detect __x more total CRC findings than CG
3 times
There were higher rates of detection in the unblinded group (__%) vs the blinded group (53%) in the detection for adenomatous/sessile serrated polyps
70% rate of detection in unblinded
__% of CRC deaths could be prevented with screening
60%
(* for your knowledge only)