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This study has been withdrawn prior to enrollment.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

April 8, 2014
June 18, 2015
January 2016
May 2017   (final data collection date for primary outcome measure)
  • 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)
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
Complete list of historical versions of study NCT02111031 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
Not Provided
 
Clinical Utility of CTC Test in Medicare-Eligible Metastatic Breast Cancer Patients
Registry to Demonstrate the Clinical Utility of CELLSEARCH® Circulating Tumor Cell (CTC) Test in Medicare-Eligible Metastatic Breast Cancer Patients

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.

Not Provided
Observational [Patient Registry]
Observational Model: Case-Only
Time Perspective: Prospective
9 Months
Not Provided
Probability Sample

"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.

  • Metastatic Breast Cancer
  • Breast Cancer
Not Provided
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).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2017
May 2017   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT02111031
JDX-2014-001
No
Janssen Diagnostics, LLC
Janssen Diagnostics, LLC
The Cleveland Clinic
Principal Investigator: Alberto Montero, MD Cleveland Clinic Main Campus
Janssen Diagnostics, LLC
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP