NCT03253575

CANscriptTM Clinical Outcomes in a Real-World Setting (ANCERS)-2

CANscriptTM Clinical Outcomes in a Real-World Setting (ANCERS)-2: A Prospective, Multicenter, Observational Study Examining the Clinical Utility of CANscriptTM in Routine Clinical Practice

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Mitra RxDx, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Detailed description

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.

Conditions

• Adult Solid Tumor

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CANscript	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.

Timeline

• Start date: 2017-07-13
• Primary completion: 2019-07-31
• Completion: 2019-12-15
• First posted: 2017-08-18
• Last updated: 2019-04-08

Locations

30 sites across 1 country: United States