Overview
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
Eligibility
Inclusion criteria:
- 18 years of age or older
- Surgically resected adenocarcinoma of the colon or rectum
- Pathologic stage II or III disease
- Selected by their healthcare provider to receive the SIGNATERA test according to the current evidence-informed schedule as part of their standard of practice
- ECOG performance status 2
- Clinically eligible for chemotherapy
- Able to tolerate collection of up to 20 mL of blood via venipuncture for research blood draw
- Has residual FFPE specimen available for submission to Natera
- Able to read, understand and provide written informed consent
- Willing and able to comply with the study requirements
Exclusion Criteria:
- Pregnant or breastfeeding
- Radiologic evidence of distant metastases
- Prior history and treatment for any cancer within the past year or has another active cancer, with the exception of non-melanoma skin cancer
- Has a known rare inherited genetic condition, with the exception of lynch syndrome
- Has initiated adjuvant chemotherapy
- Neuropathy > grade 2
- History of bone marrow or organ transplant
- Blood transfusion within 1 month of enrollment
- Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder
- Serious medical condition that may adversely affect ability to participate in the study
Control Arm Inclusion criteria:
- 18 years of age or older at time of diagnosis
- Pathologic stage II or III colorectal cancer
- Had an ECOG performance status 2 at time of diagnosis
- Were clinically eligible for chemotherapy at full recommended doses per investigator
- Received treatment no more than 3 years prior to study start date
- Have a minimum of least 2 years clinical follow-up data
Control Arm Exclusion criteria:
- Female patients that were pregnant or breastfeeding during historical control collection period
- Radiologic evidence of distant metastases
- Per investigator, was not clinically eligible for systemic chemotherapy