Colorectal Cancer Clinical Trial
Official title:
BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer
The BESPOKE CRC study will prospectively enroll patients who have undergone surgery for stage I to IV 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 post-operative systemic therapy 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 I to IV CRC cases that have a minimum of least 2 years clinical follow-up data.
Primary Objectives: - Examine the impact of SIGNATERA™ on adjuvant treatment decisions - Determine the rate of recurrence of patients diagnosed with CRC while asymptomatic using SIGNATERA™ Secondary objectives: - Molecular residual disease clearance as assessed by SIGNATERA™ - Percent of patients undergoing surgery for oligometastatic recurrence - Survival in patients treated with adjuvant versus no adjuvant chemotherapy in patients with SIGNATERA™ negative test results - Overall survival - Impact of SIGNATERA™ test results on patient quality of life ;
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