NCT04264702

BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,788 (actual)
• Sponsor: Natera, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Colorectal Cancer
• Colon Cancer

Timeline

• Start date: 2020-04-24
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2020-02-11
• Last updated: 2023-12-12

Locations

1 site across 1 country: United States