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

This study has been withdrawn prior to enrollment.
(The company decided not to start the study.)
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Janssen Diagnostics, LLC
ClinicalTrials.gov Identifier:
NCT02111031
First received: April 8, 2014
Last updated: June 18, 2015
Last verified: June 2015
  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. 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.


Condition
Metastatic Breast Cancer
Breast Cancer

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 9 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:
  • 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) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 15 Months ] [ Designated as safety issue: No ]
    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:
  • 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) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: 60 months ] [ Designated as safety issue: No ]
    Overall survival, calculated as the median (+/- standard deviation [SD]) length of time from initial diagnosis to death.


Enrollment: 0
Study Start Date: January 2016
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Case
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).

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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:

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
  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

Locations
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
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: June 18, 2015
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 27, 2015