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.
Additional locations may be listed on ClinicalTrials.gov for NCT03253575.
See trial information on ClinicalTrials.gov for a list of participating sites.
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.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMitra RxDx, Inc.