Clinical Utility of CTC Test in Medicare-Eligible Metastatic Breast Cancer Patients (Novitas)
The objective of the registry study is to demonstrate the clinical utility of the CELLSEARCH® CTC Test among the Medicare-Eligible metastatic Breast Cancer (mBC) patients in the United States. The objective of the present registry is to demonstrate the impact on patient management of the CELLSEARCH® CTC Test among the Medicare-eligible mBC patients. Hereto the hypothesis that the availability of CTC information provides clinicians important, timely information and changes treatment decisions, will be tested.
This study is IDE-exempt since CELLSEARCH® CTC Test is a legally marketed device in the US, and is being used in accordance with its labeling.
Metastatic Breast Cancer
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Target Follow-Up Duration:||15 Months|
|Official Title:||Registry to Demonstrate the Clinical Utility of CELLSEARCH® Circulating Tumor Cell (CTC) Test in Medicare-Eligible Metastatic Breast Cancer Patients|
- Incidence of mBC treatment modifications [ Time Frame: 15 months ] [ Designated as safety issue: No ]The incidence of mBC treatment modifications, calculated by dividing the total number of mBC treatment modifications by the total time at risk.
- mBC treatment modification during the follow-up time between cases and their selected matched controls. [ Time Frame: 12 months ] [ Designated as safety issue: No ]The proportion of patients who experienced mBC treatment modification anytime during the minimum follow-up time between selected matched controls. Treatment modification can be any type of change in mBC treatment, including switching, discontinuation, or augmentation of mBC Treatments.
- The durations of mBC treatments prior to modification [ Time Frame: 12 months ] [ Designated as safety issue: No ]The durations of mBC treatments prior to modification, calculated as the mean (+/- standard deviation [SD]) length of all ful during follow-up. Full treatment courses during follow-up. Full treatment courses will be defined as courses for which both the start and end dates occurred during follow-up.
|Study Start Date:||January 2015|
|Estimated Study Completion Date:||May 2017|
|Estimated Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
Patients with documented (histologically/pathologically confirmed) mBC diagnosis, at lease 65 years of age at documented mBC diagnosis, and actively treated by a physician at a participating cancer center who routinely (i.e., test at lease every quarter) use CTC testing (excluding patients who sought consults or second opinions).
Please refer to this study by its ClinicalTrials.gov identifier: NCT02111031
|Contact: Alberto Montero, MDfirstname.lastname@example.org|
|United States, Pennsylvania|
|Abramson Cancer Center, University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Alberto Montero, MD||Cleveland Clinic Main Campus|