Clinical Utility of CTC Test in Medicare-Eligible Metastatic Breast Cancer Patients

Registry to Demonstrate the Clinical Utility of CELLSEARCH® Circulating Tumor Cell (CTC) Test in Medicare-Eligible Metastatic Breast Cancer Patients

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02111031

Enrollment

Registered

2014-04-10

Start date

2016-01-31

Completion date

2017-05-31

Last updated

2015-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Metastatic Breast Cancer

Keywords

CELLSEARCH, CTC, metastatic breast cancer, Registry, mBC

Brief summary

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 impacts 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

Patient has documented (histologically/pathologically confirmed) mBC diagnosis * Patient is at least 65 years of age at time of mBC diagnosis * Patient is male or female * Patient is being actively treated at the cancer center by a physician who uses or plans to use CTC testing on his mBC patients at lease every quarter.

Exclusion criteria

* Patients breast cancer is secondary not primary

Design outcomes

Primary

Measure	Time frame	Description
Percentage of treatment decisions that are indicated to be changed by the availability CTC results, stratified by relevant criteria (e.g. patient and tumor characteristics, concordance and discordance with other test results)	15 months	Percentage of treatment decisions that are indicated to be changed by the availability CTC results, stratified by relevant criteria (e.g. patient and tumor characteristics, concordance and discordance with other test results).
The percentage of treatment decisions for which CTC results are indicated to add value to treatment decision making, stratified by relevant criteria (e.g. patient and tumor characteristics, concordance and discordance with other test results)	15 Months	The percentage of treatment decisions for which CTC results are indicated to add value to treatment decision making, stratified by relevant criteria (e.g. patient and tumor characteristics, concordance and discordance with other test results)

Secondary

Measure	Time frame	Description
The relative value of CTC testing in treatment decisions as compared to other parameters, stratified by relevant criteria (e.g. patient and tumor characteristics, concordance and discordance with other test results)	15 months	The relative value of CTC testing in treatment decisions as compared to other parameters, stratified by relevant criteria (e.g. patient and tumor characteristics, concordance and discordance with other test results)
Overall survival, calculated as the median (+/- standard deviation [SD]) length of time from initial diagnosis to death.	60 months	Overall survival, calculated as the median (+/- standard deviation \[SD\]) length of time from initial diagnosis to death.

Countries

United States

Outcome results