Table 3.
Emerging Non-Invasive, Lab-Based Strategies for CRC Screening
| Later phase, large-scale prospective studies | |||||
|---|---|---|---|---|---|
| Study | Specimen Source | Assay/Approach | Study Design | Enrolled subjects (n) | Test Characteristics |
| Evaluation of the ctDNA LUNAR Test in an Average Patient Screening Episode (ECLIPSE)(90) | Blood | Measurement of ctDNA | Observational study of average risk patients ages 45–84 years old, undergoing routine CRC screening | 22,877 | CRC sensitivity: 83%, CRC Specificity: 90%, AA Sensitivity: 13%* |
| Prevention of Colorectal Cancer Through Multiomics Blood Testing (PREEMPT CRC)(92) | Blood | Measurement of tumor and non-tumor derived signals from ctDNA, epigenetic and protein biomarkers | Observational study of average risk patients ages 45–85 | >30,000 | Not published yet, prior data from earlier trial shows CRC sensitivity: 94%, CRC Specificity: 94%* |
| Colorectal Cancer and Pre-Cancerous Adenoma Non-Invasive Detection Test Study (CRC-PREVENT)(40) | Stool | Multi-target stool RNA test plus a FIT | Interventional study of average risk individuals >45 years of age | 8,289 | CRC sensitivity: 94%, AA sensitivity: 45%, Specificity: 88% |
| Clinical Validation of An Optimized Multi-target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening “BLUE-C”(93) | Stool | Mt-sDNA 2.0 screening test | Observational study including patients age 40 and older who are enrolled in screening colonoscopy and will also complete mt-sDNA 2.0 test and FIT | 23,494 | CRC sensitivity: 94%, CRC Specificity: 91%, AA Sensitivity: 43%* |
| Early phase studies | |||||
| Sample Collection Study for the CellMax Life Circulating Tumor Cell and Circulating Tumor DNA Platforms for the Early Detection of Colorectal Cancer and Adenomas (91) | Blood | Evaluation of aberrations in ctDNA via NGS, detection of circulating epithelial cells | Observational study of average risk patients ages 45–80 | 1,038 | CRC sensitivity: 92.1%, AA sensitivity: 54.5%, AA specificity: 91%* |
| Collection of Samples USOPTIVAL Study (96) | Blood | Evaluation of cell-free DNA methylation and fragmentation characteristics, tumor-derived signal deduction and machine learning algorithm | Observational study of patients between the ages of 45 and 84 who were either average risk or had suspected AA or newly diagnosed CRC that has not been resected | 997 | CRC sensitivity: 93%, AA sensitivity 54%, AA specificity: 92%* |
| Non-invasive Identification of Colorectal Cancer and Adenomas in Early Stages (NICE)(95) | Blood | InterVenn Glycoprotein test | Prospective, multi-site study using glycoproteomic testing for early detection of advanced adenoma and colorectal cancer for average-risk patients undergoing routine screening colonoscopy | 575 | Not available |