ctDNA Therapy in Colorectal Cancer
a study on: BESPOKE
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Trial 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.
Eligibility:
Inclusion
- 18 years of age or older.
- Planning or undergone surgical resection of adenocarcinoma of the colon or rectum.
- Pathologic stage II or III disease.
- Clinically eligible for chemotherapy.
Exclusion
- 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.
- History of bone marrow or organ transplant.
Details:
Status:
Active/Enrolling
Sponsor:
Natera
ClinicalTrials.gov ID:
Study Type:
Observational
Category:
Oncology/GI
