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BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer
Trial Status: closed to accrual
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.
Inclusion Criteria
18 years of age or older.
Planning or undergone surgical resection of adenocarcinoma of the colon or rectum.
Diagnosis of Colorectal cancer that falls into one of the below categories:
Stage I to IV disease.
Stage IV with oligometastatic disease eligible for post-operative systemic therapy.
Selected by their healthcare provider to receive the SIGNATERA™ test according to the current evidence-informed schedule as part of their routine practice.
ECOG performance status ≤ 2
Clinically eligible for post-operative systemic therapy.
Able to tolerate venipuncture for research blood draw(s).
Able to read, understand and provide written informed consent .
Willing and able to comply with the study requirements.
Exclusion Criteria
Pregnant or breastfeeding.
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 post-operative systemic therapy.
Neuropathy > grade 2.
History of bone marrow or organ transplant.
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
Additional locations may be listed on ClinicalTrials.gov for NCT04264702.
