BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer
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- STATUS
- Recruiting
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- participants needed
- 1000
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- sponsor
- Natera, Inc.
Summary
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.
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
Details
| Condition | Colorectal Cancer, Colorectal Cancer, Rectal disorder, Malignant neoplasm of colon |
|---|---|
| Age | 18-100 years |
| Clinical Study Identifier | NCT04264702 |
| Sponsor | Natera, Inc. |
| Last Modified on | 19 February 2024 |
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