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

Withdrawn

• Conditions: Metastatic Breast Cancer; Breast Cancer

• Registration Number: NCT02111031
• Lead Sponsor: Janssen Diagnostics, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-08
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-10
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-18
• Last Update Posted: 2015-06-19
• Study Start: 2016-01
• Primary Completion: 2017-05
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States

Abramson Cancer Center, University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States