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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2014 by Janssen Diagnostics, LLC
The Cleveland Clinic
Information provided by (Responsible Party):
Janssen Diagnostics, LLC Identifier:
First received: April 8, 2014
Last updated: November 18, 2014
Last verified: November 2014

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 changes 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.

Metastatic Breast Cancer
Breast Cancer

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 15 Months
Official Title: Registry to Demonstrate the Clinical Utility of CELLSEARCH® Circulating Tumor Cell (CTC) Test in Medicare-Eligible Metastatic Breast Cancer Patients

Resource links provided by NLM:

Further study details as provided by Janssen Diagnostics, LLC:

Primary Outcome Measures:
  • Incidence of mBC treatment modifications [ Time Frame: 15 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 time at risk.

Secondary Outcome Measures:
  • 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 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 ful during follow-up. 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.

Estimated Enrollment: 125
Study Start Date: January 2015
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Patients with documented (histologically/pathologically confirmed) mBC diagnosis, 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).


Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.


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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02111031

Contact: Alberto Montero, MD

United States, Pennsylvania
Abramson Cancer Center, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Janssen Diagnostics, LLC
The Cleveland Clinic
Principal Investigator: Alberto Montero, MD Cleveland Clinic Main Campus
  More Information

No publications provided

Responsible Party: Janssen Diagnostics, LLC Identifier: NCT02111031     History of Changes
Other Study ID Numbers: JDX-2014-001
Study First Received: April 8, 2014
Last Updated: November 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Diagnostics, LLC:
metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases processed this record on May 29, 2015