TEST:

Cologuard®

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

''Exact Sciences Corp...today announced new data being presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting, taking place October 24–29, 2025, at the Phoenix Convention Center in Phoenix, Arizona. The company’s research showcases leadership in advancing colorectal cancer (CRC) screening through high-quality science, real-world evidence, and innovations that improve screening adherence and access across diverse patient populations.''

This project demonstrates that practical, multifaceted, low-cost strategies of provider-focused education and patient-directed digital outreach can significantly improve Cologuard usage, ultimately leading to an increase in CRC screening completion rates. Sustained reinforcement and improvement in kit return will be a key to future improvements.

P=N/A, N=150000, Active, not recruiting, Exact Sciences Corporation | Trial completion date: Dec 2029 --> Dec 2025

P=N/A, N=400, Enrolling by invitation, University of California, San Diego | Trial completion date: Jun 2027 --> Sep 2027 | Initiation date: Jun 2025 --> Sep 2025 | Trial primary completion date: Jun 2026 --> Sep 2026