Table 5.
Clinical trials using minimal residual disease tests to predict recurrence with median lead time.
| MRD Test | Cancer Type | # of Patients | Specificity | Sensitivity | Lead Time | Additional Info | Citation |
|---|---|---|---|---|---|---|---|
| RaDaR™ | NSCLC | 77 | 95.9% (47/49) | 64.8% (18/28) | 212.5 days | ctDNA detected >2 weeks after surgery | [219] |
| RaDaR™ | HNSCC | 17 | 100% (12/12) | 100% (5/5) | 122 days | ctDNA detected from samples taken during routine follow-up visits |
[220] |
| RaDaR™ | BC | 22 | 100% (5/5) | 100% (17/17) | 386.7 days | ctDNA detected from samples taken during routine follow-up visits |
[221] |
| RaDaR™ | BC | 38 | 94.1% (16/17) | 71.4% (15/21) | 92 days | ctDNA detected from samples taken at detection of recurrence or 3 years later |
[222] |
| Signatera | BC | 49 | 100% (31/31) | 89% (16/18) | 267 days | ctDNA detected from samples taken every 6 months | [103] |
| Signatera | CRC | 75 | 98.3% (58/59) | 87.5% (14/16) | 261 days * | ctDNA detected from samples taken at 1 month and every 3 months. | [223] |
| Signatera | UC | 68 | 98% (48/49) | 100% (13/13) | 96 days | ctDNA detected from samples taken during routine follow-up visits |
[224] |
| Signatera | mCRC | 112 | 93.3% (14/15) | 91.4% (32/35) | 95 days | ctDNA detection with samples from two-time points | [225] |
* Only average lead time was reported. Abbreviations: NSCLC: non-small cell lung cancer; HNSCC: head and neck squamous cell carcinoma; BC: breast cancer; CRC: colorectal cancer; UC: urothelial carcinoma; mCRC: metastatic colorectal cancer.