J Gastrointest Cancer. 2025 Nov 18;56(1):224. doi: 10.1007/s12029-025-01350-5.
ABSTRACT
PURPOSE: Colorectal cancer remains a leading cause of cancer deaths, highlighting the need for early detection. Cologuard®, a non-invasive stool DNA test, detects biomarkers for CRC and precancerous lesions but requires follow-up colonoscopy and has a high false-positive rate. This study evaluates colonoscopy follow-up rates and diagnostic outcomes after positive Cologuard® results.
METHODS: We conducted a retrospective cohort study using the TriNetX database, a global federated real-world data platform, to analyze patients aged ≥ 18 years who tested positive on Cologuard. The primary outcome was whether patients underwent an endoscopic procedure (colonoscopy) within 12 months of a positive result. The secondary outcome was the diagnoses made during follow-up colonoscopy, including malignant neoplasms (colorectal cancer) and benign neoplasms (polyps).
RESULTS: A total of 3,916 patients underwent Cologuard® testing, with 61.3% being female, 35% male, and 3.7% other genders. Of the 385 patients who tested positive for Cologuard® (mean age 65 ± 8.75 years), 171 (44%) underwent follow-up colonoscopy within 12 months. Of these, 10 cases (5.8%) were diagnosed with malignant neoplasms, and 56 cases (32.7%) were diagnosed with benign neoplasms (polyps).
CONCLUSION: 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.
PMID:41252050 | DOI:10.1007/s12029-025-01350-5
