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 April 2014 by Janssen Diagnostics, LLC
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Janssen Diagnostics, LLC
ClinicalTrials.gov Identifier:
NCT02111031
First received: April 8, 2014
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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 of Jurisdiction J12 adn JH. Specifically, the proportion and timing of treatment switching among CTC-tested and untested mBC patients will be described and compared. Further, the impact of CTC testing on physician behavior with respect to CTC test results will be evaluated via a one-time physician survey.

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.


Condition
Metastatic Breast Cancer
Breast Cancer

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Registry to Demonstrate the Clinical Utility of CELLSEARCH® Circulating Tumor Cell (CTC) Test in Medicare-Eligible Metastatic Breast Cancer Patients - Jurisdiction J12 and Jurisdiction JH Perspective

Resource links provided by NLM:


Further study details as provided by Janssen Diagnostics, LLC:

Primary Outcome Measures:
  • Incidence of mBC treatment modifications [ Time Frame: 12 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 person-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 cases and their 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 '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: 350
Study Start Date: May 2014
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Case
Patients with documented (histologically/pathologically confirmed) mBC diagnosis less than or equal to 6 months before registry enrollment with metastatic breast cancer, diagnosis of metastases secondary to breast cancer, date of diagnosis for metastases on or after date of diagnosis for breast cancer who are female gender, 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).
Control Pool
Patients with documented mBC diagnosis ICD-9 codes (ICD-9 codes: 174.xx [breast]; 196.xx, 197.xx and 198.xx [secondary malignancies]), diagnosis of metastases secondary to breast cancer, date of diag. for mets on or before date of diag. for breast cancer, actively treated by a MD at a cancer center in the Altos OncoEMR™ system who does not incorporate CTC testing in their management of mBC patients, such that the pt. has no record of CTC use at all (excluding patients who sought consults or second opinions).

  Eligibility

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.

Criteria

Inclusion Criteria:

Patients meeting all of the following criteria will be eligible for registry enrollment as cases:

  • Documented (histologically/pathologically confirmed) mBC diagnosis ≤6 months before registry enrollment by meeting all of the following:

    • Metastatic Breast Cancer
    • Diagnosis of Metastases secondary to breast cancer
    • Date of diagnosis for metastases on or after date of diagnosis for breast cancer
  • 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:

  • Patient's 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 ClinicalTrials.gov identifier: NCT02111031

Contacts
Contact: Alberto Montero, MD montero2@ccf.org

Sponsors and Collaborators
Janssen Diagnostics, LLC
The Cleveland Clinic
Investigators
Principal Investigator: Alberto Montero, MD Cleveland Clinic Main Campus
  More Information

No publications provided

Responsible Party: Janssen Diagnostics, LLC
ClinicalTrials.gov Identifier: NCT02111031     History of Changes
Other Study ID Numbers: JDX-2014-001
Study First Received: April 8, 2014
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Diagnostics, LLC:
CELLSEARCH
CTC
metastatic breast cancer
mBC
Novitas
Registry

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 19, 2014