The purpose of this study is to test the CANscript™ sensitivity assay, which is a new and different assay developed to test the sensitivity of different cancer types to physician selected therapies (both drugs and/or drug combinations) indicated for the stage and type of cancer for treatment. CANscript™ tests how a patients specific tumor reacts to the therapies being considered by the treating physician. CANscript™ test results have been shown to closely correspond with actual clinical results, providing physicians with information that may help him/her develop a more personalized cancer treatment and care plan based on the patients specific condition. The researchers want to see if CANscript™ test results are helpful in selecting the treatments prescribed and provided. There will be about 800 people taking part in this study, across 5 different tumor types. The study is designed to assess the decision impact of the CANscript™ test results in informing physicians in therapy selection.
This is an observational data collection study evaluating how physicians utilize therapeutic sensitivity information ascertained with CANscript, and subsequently describing clinical outcomes (clinical response and survival) resulting from their therapeutic selection. Potential patients presenting for study enrollment will provide written informed consent and will subsequently be screened per inclusion/ exclusion criteria. Once enrolled, a biopsy \& blood draw will be scheduled to obtain material for CANscript testing. Imaging will also be scheduled if a fresh image (obtained within 14 days of planned treatment initiation) is not available. Prior to submitting a fresh tissue sample for CANscript, the treating physician will select any number of therapies being considered for treatment, and will assign a priority ranking to those therapies (priority #1 through priority #N, with #1 representing their most preferred therapeutic option for the patient, and #N representing the number of their least preferred of the appropriate potential therapies). Prioritized therapies can be either single-agent therapeutics or combination regimens. All ranked therapeutic options must be available for individual patient at the time of selection. The prioritized list of preferred therapies will be sent to the testing laboratory (Mitra Biotech, Inc.) at least 2 days before the biopsy and blood draw are performed. Fresh tumor and blood samples will subsequently be sent to the testing laboratory for receipt within 24 hours of biopsy.
Study Type
OBSERVATIONAL
Enrollment
800
CANscript is a predictive test that supports informed selection of cancer therapeutics for each individual patient. CANscript has the potential to predict the response of the patient under evaluation to either single-agent cancer therapeutics or combination therapeutic regimens. This is accomplished by using fresh tumor tissue from the patient in plates coated with a specific set of tumor matrix proteins (TMP). Further, patient derived autologous ligands are added to the culture. Angiogenic factors are added to maintain tumor vasculature along with autologous immune cells. In essence, CANscript recapitulates the tumor microenvironment.
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
University of Colorado School of Medicine-Denver
Aurora, Colorado, United States
Eastern CT Hematology and Oncology Associates
Norwich, Connecticut, United States
Lynn Cancer Institute
Boca Raton, Florida, United States
Broward Oncology Associates
Fort Lauderdale, Florida, United States
CANscript decision impact will be captured via a study specific questionnaire
1\. A questionnaire will be used to capture the information to be able to summarize the concordance and discordance rates between: 1. Empirically selected therapy (selected by treating physicians prior to knowing the CANscript results for a given patient) and CANscript recommended therapy (i.e., the therapy with the highest CANscript M-score for a given patient). 2. Empirically selected therapy and CANscript results that predict response or non-response.
Time frame: 18-24 months
The RECIST 1.1 criteria will utilized to assess therapy response, i.e. Complete Response (CR), Partial Response (PR), Stable Disease (SD), Duration of Response (DoR), Progression Free Survival (PFS)
A baseline Image will be taken prior to therapy initiation, and then as per tratment guidelines throughout and following therapy delivery: 1\. To summarize tumor response in terms of objective response rate (ORR), clinical benefit rate (CBR), duration of response (DoR) progression-free survival (PFS), and overall survival (OS) based on imaging (CT, MRI, etc.) and scoring per RECIST 1.1 criteria.
Time frame: 24-48 months
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Holy Cross Hospital
Fort Lauderdale, Florida, United States
University of Miami-Sylvester Comprehensive Cancer Center
Miami, Florida, United States
The Center for Gyencologic Oncology
Miramar, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Tallahassee Memorial Cancer Center
Tallahassee, Florida, United States
...and 20 more locations