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

NCT02111031 | Withdrawn

• 1 other identifier: JDX-2014-001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Metastatic Breast Cancer; Breast Cancer

Keywords

CELLSEARCH; CTC; metastatic breast cancer; Registry; mBC

Outcome Measures

Primary Outcomes (2)

• 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)

  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

• 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)

  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

Secondary Outcomes (2)

• 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

• Overall survival, calculated as the median (+/- standard deviation [SD]) length of time from initial diagnosis to death.

  60 months

Study Arms (1)

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 Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients breast cancer is secondary not primary

Sponsors & Collaborators

• Janssen Diagnostics, LLC: lead
• The Cleveland Clinic: collaborator

Study Sites (2)

Abramson Cancer Center, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Alberto Montero, MD

  Cleveland Clinic Main Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 10, 2014
• Study Start: January 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: June 19, 2015

Record last verified: 2015-06

Locations

US (2)