TEST:

Cologuard®

P=N/A, N=140, Completed, UConn Health | Recruiting --> Completed | N=200 --> 140 | Trial completion date: Dec 2026 --> Jan 2026

Scenario modeling using BLUE-C prevalence estimates suggests that improving APL sensitivity from approximately 43% to 55-65% at ~94% specificity could translate to detecting roughly 13-23 additional advanced precancerous lesions per 1000 individuals screened, highlighting the potential prevention impact of a multi-omic approach. This framework aims to guide developers and clinical investigators toward next-generation stool tests capable of materially improving precursor-lesion detection while maintaining clinically acceptable specificity.

The patient had no adverse events, demonstrating the technical success of EMD in achieving en bloc R0 resection. EMD achieved en bloc R0 resection, highlighting its efficacy as a minimally invasive, organ-sparing approach for precise staging of rectal cancer.

P=N/A, N=205, Completed, Dartmouth-Hitchcock Medical Center | N=382 --> 205

Abnormal findings occurred in 57.9% of colonoscopies, 18.7% of Cologuard tests, 33.3% of mammograms, and 0% of Pap smears. This student-led outreach to patients overdue for cancer screenings facilitated referrals for colorectal, breast, and cervical cancer, supported early detection of abnormalities, and provided students with hands-on experience in preventive medicine, fostering development as community-focused physicians.

P=N/A, N=5127, Completed, Massachusetts General Hospital | Active, not recruiting --> Completed

Conditional NPVs for AA and CRC after negative mt-sDNA were 91.6% and 99.2%. Proximal lesions were more likely to be missed, highlighting the need for meticulous examination. Negative mt-sDNA results should be interpreted cautiously, particularly in symptomatic patients, and colonoscopy should be pursued when clinically indicated.

Lastly, we address the current challenges faced in using these biomarkers in a clinical setting. Despite the obstacles, these non-invasive and reliable markers have the potential to enable early detection of CRC and likely increase screening uptake, potentially replacing current modalities.

The study found poor follow-up adherence, with only 44% completing colonoscopy and a high false positive rate with just 38.5% of positive Cologuard® results showing significant lesions. These findings emphasize the need for better patient education, streamlined care pathways, and improved communication to enhance follow-up compliance.

P=N/A, N=100, Active, not recruiting, University of California, San Diego | Trial completion date: Apr 2025 --> Dec 2025