Preoperative Plasma ctDNA Detection in Early Stage Cancer: a Proof-of-Concept Evaluation

The primary objective of this study is to evaluate the feasibility of using a novel, highly specific and sensitive SuperSelective PCR approach to detect specific oncogenic mutations in the plasma of patients with resectable, early-stage lung and colon cancers, which will be achieved by correlating those results with disease site, histology, pathological stage, tumor variant allele frequency, and volume.

Secondarily, we will assess the effectiveness of this approach in detecting residual disease (correlated with 2-year disease-free survival and overall survival outcomes) when applied at 6-month intervals over a total of 2 years on the study.

Lastly, we will explore the sensitivity of SuperSelective PCR in detecting ctDNA of cancer patients (regardless of tumor type) with known tumor alterations that were not previously detected using commercially available, CLIA-certified ctDNA analyses.

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