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 of Jurisdiction J12 adn JH. Specifically, the proportion and timing of treatment switching among CTC-tested and untested mBC patients will be described and compared. Further, the impact of CTC testing on physician behavior with respect to CTC test results will be evaluated via a one-time physician survey.
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:||12 Months|
|Official Title:||Registry to Demonstrate the Clinical Utility of CELLSEARCH® Circulating Tumor Cell (CTC) Test in Medicare-Eligible Metastatic Breast Cancer Patients - Jurisdiction J12 and Jurisdiction JH Perspective|
- Incidence of mBC treatment modifications [ Time Frame: 12 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 person-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 cases and their 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 '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:||May 2014|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Patients with documented (histologically/pathologically confirmed) mBC diagnosis less than or equal to 6 months before registry enrollment with metastatic breast cancer, diagnosis of metastases secondary to breast cancer, date of diagnosis for metastases on or after date of diagnosis for breast cancer who are female gender, 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).
Patients with documented mBC diagnosis ICD-9 codes (ICD-9 codes: 174.xx [breast]; 196.xx, 197.xx and 198.xx [secondary malignancies]), diagnosis of metastases secondary to breast cancer, date of diag. for mets on or before date of diag. for breast cancer, actively treated by a MD at a cancer center in the Altos OncoEMR™ system who does not incorporate CTC testing in their management of mBC patients, such that the pt. has no record of CTC use at all (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|
|Principal Investigator:||Alberto Montero, MD||Cleveland Clinic Main Campus|