LynnMarie wrote:Can you share any details about the Signatera study? I would love to enroll! Thanks!
Signatera is a custom-built circulating tumor DNA (ctDNA) test that received the FDA Breakthrough Device Designation in 2019
US-based cell-free DNA testing company Natera has started enrolment for two clinical trials, dubbed CIRCULATE-Japan and BESPOKE CRC, to measure clinical outcomes of Signatera molecular residual disease (MRD) testing for resectable stages II-IV colorectal cancer (CRC).
BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer
The BESPOKE CRC study will prospectively enroll patients who have undergone surgery for stage II or III colorectal cancer (CRC) and who have residual formalin-fixed paraffin-embedded (FFPE) tissue available will provide FFPE and whole blood samples. Patients will receive SIGNATERA™ test results and may be recommended for adjuvant chemotherapy or observation by their treating clinician. Patients will be followed for up to two years with periodic whole blood collection. The study also has a control arm that will consist of matched Stage II or Stage III CRC cases that have a minimum of least 2 years clinical follow-up data.
Reference: BESPOKE CRC clinical trial: NCT04264702
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