This study is going to test the ability to successfully obtain results from certain personalized tests for patients with biliary tract cancers that are able to be surgically removed. Through surveys, this study will also evaluate the usefulness of these tests to medical oncologists as they make decisions on what standard or experimental treatments might benefit the patient's enrolled in the study. The study is observational and does not require any change in the standard approach to treating biliary tract cancer. Results of the personalized tests will be provided to the treating medical oncologist and the medical oncologist can choose to whether or not to change management based on these results. These personalized tests include reading of the cancer DNA, testing whether a panel of drugs can kill a patient's cancer cells in a test tube, and testing for small amounts of cancer DNA in the blood as a way to check for the presence of leftover cancer in the body after it is removed surgically. This study will also give extra pieces of cancer, that would otherwise be discarded, from surgery for laboratory research into how biliary tract cancers respond to drugs and the body's immune system. The investigators hypothesize that the drug screen test will, in some cases, be useful to the medical oncologist and may lead to the use of cancer drugs that would not otherwise have been chosen based on standard guidelines or based on cancer DNA testing. The investigators hypothesize that the test tube drug screening method will correlate with how the cancer responds to the drugs in real life for those patients that end up receiving a drug that was included in the drug screen panel. The investigators hypothesize that monitoring of cancer DNA in the blood stream will help us predict which patients are most likely to have their cancer return after surgery. The investigators also hypothesize that in many cases the appearance of cancer DNA in the blood stream will happen weeks to months prior to the cancer showing up on usual body imaging or other lab tests. Finally, the investigators hypothesize that, for patients undergoing medical treatment for their cancer, trends in the amount of cancer DNA in the blood stream will correlate with the effectiveness of treatment.
Study Type
OBSERVATIONAL
Enrollment
14
All patients in the study will have organoid creation and organoid drug sensitivity screening attempted on their fresh tumor tissue from surgical resection. All patients will also have blood taken pre-operatively and at multiple post-operative time points to monitor circulating tumor DNA.
University of Illinois at Chicago
Chicago, Illinois, United States
University of Washington
Seattle, Washington, United States
Success Rate of Organoid Culture and Drug Screen
The investigators will measure the percentage of patients for whom organoids are able to be successfully cultured and subjected to a drug screen.
Time frame: Within 12 weeks after surgery
Success Rate of Obtaining circulating tumor DNA (ctDNA) quantification and Ability to assess change in ctDNA levels across those time points
The investigators will measure the percentage of patients for whom ctDNA was able to be collected and quantified at multiple key time points across the course of a patient's treatment.
Time frame: Through study completion, an average of 4 years.
Physician-Adjudicated Utility of Profiling Test Results - Post-Adjuvant Therapy
Through surveys, the investigators will ask cancer physicians how helpful the profiling test results are anticipated to be to the ultimate management of the patient after they have received adjuvant chemotherapy.
Time frame: At the time of completion of adjuvant therapy, on average 6 months after surgery.
Prospective Concordance of Organoid Drug Screen Results and In Vivo Drug Activity
For patients that are treated with drugs that were also evaluated by the initial organoid drug screen, the investigators will measure how often the organoid's response to the drug paralleled the response of the cancer to the drug when administered to the patient.
Time frame: Through study completion, an average of 4 years.
Predictive Value of circulating tumor DNA (ctDNA) for Recurrence
The investigators will evaluate how often measurable post-operative ctDNA levels were able to predict ultimate recurrence of clinical disease. The investigators will measure the lead time of ctDNA-assessed recurrence over radiographic recurrence.
Time frame: From date of randomization until the date of first documented radiographic recurrence, an average of 2 years after surgery.
Concordance of Organoid Drug Screen Results with Next Generation Sequencing (NGS)-Predicted Drug Sensitivities
The investigators will evaluate how often the organoid drug screen responded to a drug that genomic profiling by NGS would have predicted the cancer would be sensitive to.
Time frame: Within 12 weeks after surgery when results of NGS and Organoid Drug Screen have returned.
Physician-Adjudicated Utility of Profiling Test Results - At Time of Recurrence
Through surveys, the investigators will ask cancer physicians how helpful the profiling test results were to the ultimate management of the patient at the time their cancer recurred.
Time frame: At the time of cancer recurrence, on average 24 months after surgery.
Predictive Value of circulating tumor DNA (ctDNA) for Response to Medical Therapy
The investigators will correlate ctDNA level trends with radiographic responses to medical treatments.
Time frame: Through study completion, an average of 4 years.
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