Clinical Trial TitleBESPOKE Study of ctDNA Guided Therapy in Colorectal Cancer
National Clinical Trial Number:NCT0426470
Clinical Trial Protocol Description:
Subjects are being asked to participate in this study because subjects are over the age of 18, and subjects have been diagnosed with either stage II or III colorectal cancer and have undergone surgery or will shortly undergo surgery. Subject and subject’s doctor have decided subject will have Signatera™ ctDNA testing performed as part of subject’s routine care. Signatera is a laboratory test that uses DNA from a tissue sample to measure tumor DNA in the blood. This is an observational study, which means it will not change the regular medical care subjects will receive from subject’s doctor. The study is being done to better understand how Signatera results are used to manage care of patients with colorectal cancer. The test that will be used for ctDNA (circulating tumor DNA) testing is a diagnostic test called Signatera. The test can only be used in the certified laboratory that developed the test. Subject and subject’s doctor have decided subject will have Signatera ctDNA testing performed as part of subject’s routine care.
Patients will receive SIGNATERATM test results and may be recommended for chemotherapy or observation by their treating healthcare provider (HCP). Patients will be followed for up to two (2) years with periodic whole blood collection. Treatment administered, disease-free survival, overall survival, time to recurrence, physician questionnaires and patient-reported outcomes will be collected/recorded.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older.
- Have surgically resected adenocarcinoma of the colon or rectum.
- Have pathologic stage II or III disease.
- Have been selected by your healthcare provider to receive the SIGNATERA™ test according to the current evidence-informed schedule as part of your standard of practice.
- Have an ECOG performance status ≤ 2.
- Are clinically eligible for chemotherapy.
- Are able to tolerate collection of up to 20 mL of blood via venipuncture for research blood draw.
- Have residual FFPE specimen available for submission to Natera.
- Are able to read, understand and provide written informed consent.
- Are willing and able to comply with the study visit schedule and study requirements.
You will be excluded from the study if any of the following criteria apply to you:
- Are pregnant or breastfeeding.
- Have radiologic evidence of distant metastases.
- Have prior history and treatment for any cancer within the past year or have another active cancer, with the exception of non-melanoma skin cancer.
- Have a known rare inherited genetic condition, with the exception of Lynch syndrome.
- Have initiated adjuvant chemotherapy.
- Have neuropathy > grade 2.
- Have a history of bone marrow or organ transplant.
- Have had a blood transfusion within 1 month of enrollment.
- Have a medical condition that would place the you at risk as a result of blood donation, such as bleeding disorder.
- Have a serious medical condition that may adversely affect ability to participate in the study.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.
Clinical Trial Investigator
RUSH University Medical Center
1620 W Harrison St
Chicago, IL 60612