GeneSearch Breast Lymph Node (BLN) Assay Timing Study

Stopped early

Conditions studied: Breast Cancer

In brief

This study is designed to collect data about the amount of time required to use the assay in clinical-use conditions.

Key facts

Study ID

NCT00595023

Run by

Janssen Diagnostics, LLC

People needed

233

Starts

2007-12-01

Expected to finish

2009-12-01

Last updated by the study team

2016-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pre-operatively established diagnosis of invasive carcinoma of the breast
• Scheduled for axillary sentinel lymph node dissection as per standard of care at the clinical site for newly diagnosed breast cancer patients
• Patients for whom the GeneSearch™ BLN Assay will be used intra-operatively to make a decision for an axillary lymph node dissection
• 18 years of age or older
• Female or male

You may not qualify if…

• Previous diagnosis of lymphoma
• Subjects participating in other research studies that would interfere with their full participation in this study
• Patients and/or conditions with 'interfering substances' as listed in the IFU
• Patients who have had any pre-operative treatment for breast cancer including neoadjuvant and/or hormonal intervention such as aromatase inhibitors or tamoxifen

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Morton Plant Hospital — Clearwater, Florida, United States
• St. Anthony's Hospital — St. Petersburg, Florida, United States
• Georgia Esoteric and Molecular Labs, LLC — Augusta, Georgia, United States
• Woman's Hospital — Flowood, Mississippi, United States

Full record on ClinicalTrials.gov

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