Last updated on September 2020

BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer

Brief description of study

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.

Detailed Study 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

Clinical Study Identifier: NCT04264702

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The Toledo Clinic

Toledo, OH United States
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Pontchartrain Cancer Center

Covington, LA United States
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New Jersey Cancer Care

Belleville, NJ United States
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Virginia Cancer Institute

Richmond, VA United States
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Summit Cancer Centers

Spokane, WA United States
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Northwest Medical

Tacoma, WA United States
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Mosaic Life Care

Saint Joseph, MO United States
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TMPN - Cancer Care

Torrance, CA United States
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Regional Cancer Care Associates

Hackensack, NJ United States
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PanOncology Trials

Rio Piedras, Puerto Rico
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Parkview Research Center

Fort Wayne, IN United States
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The West Clinic PLLC

Germantown, TN United States
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Recruitment Status: Open

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