Colon Cancer Clinical Trial
BESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer
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 SIGNATERAâ„¢ 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.
Full 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 Criteria
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 Inclusion criteria:
18 years of age or older at time of diagnosis.
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.
Were clinically eligible for chemotherapy at full recommended doses per Health Care Provider.
Received treatment no more than 3 years prior to study start date.
Have a minimum of least 2 years clinical follow-up data or reached a progression event.
Control Arm Exclusion criteria:
Female patients that were pregnant or breastfeeding during historical control collection period.
Per investigator, was not clinically eligible for post-operative systemic therapy.
Had an ECOG performance status ≤ 2 at time of diagnosis.
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There is 1 Location for this study
San Carlos California, 94070, United States
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