Two Advocate Aurora Health hospitals will evaluate the effectiveness of the SIGNATERA™ ctDNA test in detecting and monitoring residual disease in colorectal cancer patients, aiding in adjuvant treatment decisions and recurrence monitoring.
Researchers at Aurora St. Luke’s Medical Center in Milwaukee and Aurora Medical Center Summit in Summit, Wisconsin, will enroll people who have undergone surgery for stage II or III colorectal cancer. Researchers will take tumor tissue samples from consenting study participants, genetically sequence their tumors and create personalized tests to identify the presence or absence of tumor DNA in their blood, called circulating tumor DNA, or ctDNA. Study participants will also provide whole blood samples for SIGNATERA™ testing.
“Such testing may be able to determine the presence of a promising biomarker in the blood for assessing colorectal cancer recurrence and assisting with clinical decision making,” said hematologist and oncologist Antony Ruggeri, MD, Advocate Aurora Research Institute principal investigator for the study. “The test has the potential to allow for more optimal use of chemotherapy by providing a better idea of a patient’s risk of relapse and enabling early detection of colorectal cancer recurrence.”
Colorectal cancer is the fourth most frequently diagnosed cancer and second leading cause of cancer death in the U.S.
Most patients with stage II colorectal cancer do not receive chemotherapy, even though 10% to 15% show residual disease following surgery. And about 30% of patients with stage III colorectal cancer who receive chemotherapy still have residual disease and experience cancer recurrence.
Further complicating a clinician’s treatment decisions, more than 50% of patients with stage III colorectal cancer are cured by surgery alone, yet the majority go on to receive chemotherapy anyway.
“By identifying which patients show residual disease following surgery, clinicians could potentially avoid harmful chemotherapy for some patients while reducing the risk of cancer recurrence for others,” said Amit Acharya, PhD, chief research officer and system vice president for Advocate Aurora and the Research Institute.
Participants in the study will receive SIGNATERA™ test results and may be recommended for chemotherapy or observation by their treating clinician. Researchers will follow participants for up to two years with periodic whole blood collection.
The study also includes a control arm consisting of patients with stage II or III colorectal cancer who had previously undergone treatment without first having submitted samples for SIGNATERA™ testing and who have at least two years of follow-up data. Participants in the control arm will be found via the electronic medical record, and all data will be deidentified.
Researchers plan to enroll 1,000 study participants and 300 historical control cases from up to 200 total sites.
The study, “BESPOKE study of ctDNA guided therapy in colorectal cancer,” is sponsored by Natera, Inc., manufacturer of SIGNATERA™.
To learn more about Advocate Aurora’s research, visit aurora.org/research.