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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02111031
• Other study ID #: JDX-2014-001
• Status: Withdrawn
• Phase: N/A
• First received: April 8, 2014
• Last updated: June 18, 2015
• Start date: January 2016
• Est. completion date: May 2017

Study information

• Verified date: June 2015
• Source: Janssen Diagnostics, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastatic Breast Cancer

Locations

Country	Name	City	State
United States	Abramson Cancer Center, University of Pennsylvania	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Janssen Diagnostics, LLC	The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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	No
Primary	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)	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	No
Secondary	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)	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	No
Secondary	Overall survival, calculated as the median (+/- standard deviation [SD]) length of time from initial diagnosis to death.	Overall survival, calculated as the median (+/- standard deviation [SD]) length of time from initial diagnosis to death.	60 months	No