TEST:

Cologuard®

No abstract available

CMSmin could contribute to CRC control by achieving screening in those who will not use established methods. Substituting blood-based testing for established effective CRC screening methods will require higher CRC and APL sensitivities that deliver programmatic benefits matching those of FIT. High APL sensitivity, which can result in CRC prevention, should be a top priority for screening test developers. APL detection should not be penalized by a definition of test specificity that focuses on CRC only.

He holds 37 US patents and is an elected fellow of the American Institute of Medical and Biological Engineering. He is also a co-founder of Droplet Biosciences.

Stan sits on the board of over30 biomedical companies and is a professor emeritus at MIT and Harvard Business School. He is also the co-founder of DropletBiosciences.

The study encompassed 82 patients, with 40 patients (48.78%) being up-to-date with colorectal cancer screening. This screening included Colonoscopy (65% for 26 patients), FIT/Cologuard (30% for 12 patients), with no patients opting for FlexSig, and 2 patients choosing FOBT (5%). For comparison, a random cohort of patients not identifying as LGBTQ+ was chosen.

Out of 506 patients, 356 had an active electronic portal and received the message. Of those patients, 140 (39%) read the message, and only six patients (4% of readers) had an order placed screening (three for colonoscopy, one FIT, and two for Cologuard). Analysis of the 8-week period prior to electronic messages revealed 43 referrals placed for colonoscopy and five stool-based tests ordered.

Overall, we achieved a response rate of 28.6% with 38.1% of patients opting to get scheduled or were already scheduled from those who replied (Figure 2). Conclusion Personalized MyChart messages to patients are an easy, efficient, and cost-effective method to serve as reminders and engage patients in conversations related to the completion of CRC Surveillance.

This knowledge will help increase CRC screening rates, improve wait times for high-risk colonoscopies by reducing the overall patient load, and decrease inappropriate usage of Cologuard. We hope to apply these findings to our resident ambulatory clinic by improving rates of CRC screening and Cologuard prescription in an urban, underserved patient population.

Nearly 16% of patients who had a Cologuard test had a positive result. Of those with a positive result, only 359 (59%) had a follow-up screening colonoscopy. Of patients who had a followup colonoscopy after a positive Cologuard test, the sensitivity for Cologuard to detect a colorectal neoplasm (cancer, advanced polyp) was 97%.

This qualitative initiative identified that nearly 14% of all mt-sDNA tests were ordered off-label. Importantly, it appears that less than half of the patients are being screened adequately in clinic to determine the appropriateness of mt-sDNA and up to one-third of the patients did not complete the testing. As part of this quality initiative, we will be proposing an electronic order that prompts the provider to check for the appropriate indications for mt-sDNA before the testing order can be issued.

In a large retrospective cohort study, the PPV of Cologuard for detecting advanced adenomas appears to be comparable between pts not on anticoagulants or antiplatelets and those on either antiplatelet or anticoagulant agents or both agents.

These findings demonstrate the multifaceted factors influencing the preference for at-home mt-sDNA CRC screening among Alaska Native individuals. Challenges such as limited access to medical facilities, financial burdens, and personal commitments have significant bearing on the screening decision-making process. Moreover, the emotional aspect of fear and discomfort associated with colonoscopy plays a role in shaping these preferences.

We developed a novel low-cost blood-lipidomics based method for CRC detection, suitable for routine screening. Comprehensive validation through a multi-center prospective study showed similar performance to that published for the stool-cfDNA test ColoGuard, and higher performance than other published blood-cfDNA methods in the detection of early-stage CRC and AA.

P=N/A; Trial primary completion date: Oct 2023 --> Dec 2023

P=N/A; Initiation date: Jan 2024 --> Jan 2023

P=N/A; Active, not recruiting --> Completed | N=950 --> 382

P=N/A; N=11; Enrolling by invitation; Sponsor:Indiana University

P=N/A; N=8000 --> 5311

P=N/A; N=100; Not yet recruiting; Sponsor:University of California, San Diego

We conducted a survey of patients (n = 2973) who were prescribed the multi-target stool DNA (mt-sDNA) screening test (commercialized as Cologuard and manufactured by Exact Sciences Corporation) to understand attitudes and experiences that influence test completion and likelihood of future test completion. Using exploratory factor analyses, we developed three scales: Perceived Effectiveness, Perceived Ease of Use, and Perceived Comfort.

P=N/A; N=11; Enrolling by invitation; Sponsor:Indiana University

These data support that the tumor likely arose from three separate clonal populations, the BRAF V600E population and the KRAS G12G and KRAS G12C populations, each having distinct molecular pathways to tumorigenesis. Future directions include measuring spatial gene expression patterns of the tumor to correlate with the tumor mapping described above and to further characterize the multiple populations of tumor cells harboring different driver alterations and molecular pathways to tumorigenesis.

P=N/A; Enrolling by invitation --> Active, not recruiting

"Exact Sciences Corp...announced late-breaking data from the pivotal BLUE-C trial showing the next-generation Cologuard test met all study endpoints, demonstrating 94 percent sensitivity for colorectal cancer (CRC) at 91% specificity, during the American College of Gastroenterology (ACG) Annual Meeting 2023."

"Exact Sciences Corp...announced the company will present late-breaking data on next-generation Cologuard^® from the BLUE-C pivotal trial during the American College of Gastroenterology (ACG) Annual Meeting, taking place October 20-25, 2023, in Vancouver, Canada."

Most patients rescheduled their colonoscopy despite the risk of virus exposure, suggesting that concern of missed colorectal cancer diagnosis outweighed coronavirus concerns. Patient trust in referring providers may be important for rescheduling, and colonoscopy indications were independently associated with rescheduling status.

P=N/A; Active, not recruiting --> Completed | Trial completion date: Dec 2023 --> Oct 2023 | Trial primary completion date: Dec 2023 --> Jun 2023

Our observations emphasize the potential of our multiple cfDNA methylation marker-based test for CRC screening in high-risk populations.

We found a 21% reduction in the odds of CRC screening in the context of the COVID-19 pandemic. Reductions in colonoscopies and other types of screening tests were not offset by changes in the use of at-home tests such as Cologuard.

P=N/A; Active, not recruiting --> Completed

P=N/A; Recruiting --> Active, not recruiting

The study included 312 patients with a mean age of 71.4 ± 7.4 years. The majority were over 70 years old (66.4%), female (52.9%), and non-Hispanic white (93.3%), with a mean BMI of 26.6 ± 5.0. Most patients (88.8%) underwent colonoscopy within 6 months of a positive Cologuard result.

During the study period, 3444 patients had a colonoscopy for positive Cologuard. Out of these 297 (8.6%) patients with inflammatory bowel disease and 89 (2.6%) patients with a family history of colon cancer were excluded from the final analysis. Therefore, 3065 patients were included in the final analysis.

The study included 312 patients with a mean age of 71.4 ± 7.4 years. The majority of patients were over 70 years old (66.4%), female (52.9%), and non-Hispanic white (93.3%), with a mean BMI of 26.6 ± 5.0. The majority of patients (88.8%) underwent colonoscopy within 6 months of receiving positive Cologuard results.

Case Description/ A 63-year-old male with a history of coronary artery disease, on aspirin and clopidogrel, presented to the advanced endoscopy clinic for evaluation of GI bleeding with associated anemia...Numerous mitotic figures and apoptotic debris were also noted. (c) The large atypical lymphocytes express CD20 (10x objective) staining, consistent with B cell origin.

Our study included 688 individuals who identified as food insecure. 62.6% were screened for CRC (compared to 72.6% for food secure respondents). The average age was 60.4 years; 44.8% were non-Hispanic White and 23.4% were non-Hispanic Black.

420 patient charts with successfully completed Cologuard tests were identified. There were 100 high-risk patients in this cohort, albeit against USPSTF guidelines. There were 228 negative Cologuard tests.

Our cases serve to emphasize that at-home colorectal cancer screening tests should be used with caution as there remains a risk of missing polyps and even cancer. Figure: Colonoscopies following negative updated Cologuard revealing colonic masses with subsequent pathology positive for colon cancer (Figure A, B).

A total of 1,278 patients met the inclusion criteria. Comparison of ADRs from endoscopist 1 shows a pre-AI ADR of 37% compared to a post-AI ADR of 35.12%. Comparison of ADRs from endoscopist 2 shows a pre-AI ADR of 60.59% compared to a post-AI ADR of 56.82%.

A total of 284 patients were prescribed a Cologuard test, of which 159 (56.0%) completed the screening. Of the 25 (15.7%) positive results, 10 were deemed inappropriate based on risk factors including personal history of polyps, family history of colon cancer, or alarm symptoms . 18 of the 25 patients completed a diagnostic colonoscopy, 15 of which had notable findings and eight met criteria for advanced adenomas.

She had undergone modified radical mastectomy involving LN 18/23+, locoregional radiotherapy 45/50 Gy in 25 fractions, and completion of carboplatin, trastuzumab, pertuzumab chemotherapy course, later switched to adriamycin, cyclophosphamide, and letrozole due to poor tolerance. The analysis of cases as the one above can lay the groundwork in forming cohort of patients to study the polarity of metastatic patterns. Figure: (a)diffuse wall thickening of descending colon (b) coronal view, notable for gastric abutment of transverse colon (c) tissue sample demonstrating linear single-file cells, ER +, PR-, resembling histologically primary breast lesion

Out of 127,986 patient encounters 47.81% of patients presenting for routine screening colonoscopies were found to have a neoplastic lesion as compared to 65.39% and 68.94% of patients presenting after a positive FIT or mts-DNA, respectively. Adjusted for age, sex, ethnicity, and race, the odds of finding neoplastic lesions was 1.75 times higher [1.39-2.21; 95% CI] in colonoscopies indicated by abnormal FIT and 2.13 times higher [1.93-2.34; 95% CI] in colonoscopies indicated by abnormal mts-DNA than routine screening colonoscopies. The odds of finding neoplastic lesions were highest in the mts-DNA group, and higher in the FIT group than the screening colonoscopy group.