Clinical trial NCT02111031: Clinical Utility of CTC Test in Medicare-Eligible Metastatic Breast Cancer Patients
Official title: Registry to Demonstrate the Clinical Utility of CELLSEARCH® Circulating Tumor Cell (CTC) Test in Medicare-Eligible Metastatic Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Metastatic Breast Cancer
Breast Cancer
Keywords: CELLSEARCH
CTC
metastatic breast cancer
Registry
mBC
Lead sponsor: Janssen Diagnostics, LLC
Sponsor class: INDUSTRY
Collaborators: name: The Cleveland Clinic
First posted: 2014-04-10
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: "Cases" of CTC-tested mBC patients being cared for by physicians who routinely (i.e., test at least once every quarter) incorporate CTC testing in their management of mBC patients.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 15 months
measure: 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)
timeFrame: 15 Months
Secondary outcomes:
measure: 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)
timeFrame: 15 months
measure: Overall survival, calculated as the median (+/- standard deviation [SD]) length of time from initial diagnosis to death.
timeFrame: 60 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center, University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Cleveland Clinic Main Campus
name: Alberto Montero, MD
role: PRINCIPAL_INVESTIGATOR
References: