GeneSearch™ Breast Lymph Node (BLN) Assay Post Approval Study
Stopped early
Conditions studied: Breast Cancer
In brief
This post-approval study is designed to determine the performance of the FDA-approved GeneSearch™ BLN Assay when compared to the site's standard of care permanent section histological evaluation, and when compared to more extensive histological evaluation when the assay is being used by clinicians to make surgical decisions on complete axillary dissections (ALND).
Key facts
- Study ID
- NCT00595296
- Run by
- Janssen Diagnostics, LLC
- People needed
- 461
- 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
- Willing and able to give informed consent to participate in the study
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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