CORRECT-MRD II: Why is this trial being done?

Exact Sciences is developing a lab test that is designed to detect biomarkers in the blood that indicate a small amount of remaining (post-treatment) or recurrent CRC in the body.

The test is called Exact Sciences’ Minimal Residual Disease Test (Exact MRD). Blood-based biomarkers (e.g. circulating tumor DNA [ctDNA]) have the potential to provide information about the presence or absence of very small amounts of remaining or recurrent cancer. This could prove to be useful for guiding treatment decisions after surgery. It could also be a way to detect cancer recurrence earlier than the currently available monitoring tests (e.g., currently available blood tests, imaging).

As mentioned above, the purpose of this research study is to review the ability of the Exact MRD test to detect cancer recurrence after surgery. The study will also show if the Exact MRD test can detect the cancer prior to standard monitoring (e.g., currently available blood tests, imaging). This test is not approved by the United States Food and Drug Administration (FDA) or by health authorities in Canada and is considered investigational. A current Exact Sciences biomarker Laboratory Developed test, Oncotype DX Colon Recurrence Score® (Oncotype DX®), which uses tumor tissue to estimate the chance of recurrence from Stage II-III colon cancer, will also be performed. This study will also assess if using the two tests together can provide new insights.