GeneSearch™ Breast Lymph Node (BLN) Assay Post Approval Study
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The primary objective of this clinical study is to gather data to estimate the positive predictive concordance (PPC) between the GeneSearch™ BLN Assay and histology as routinely practiced, i.e., routine H&E histology of sentinel lymph node(s) (SLN) and, when available, routine histology of non-sentinel axillary lymph nodes (ALN). This study will provide information on the assay that will augment the performance data gained in pre-market validation studies. In addition, with the assay being used for ALND decision-making, the metastatic status of the non-sentinel axillary nodes can be taken into account in the performance measures, i.e., if the patient's sentinel or non-sentinel nodes are histologically positive, the patient will be considered positive for the primary comparison to the assay results.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 All eligible patients. |
Device: GeneSearch™ Breast Lymph Node (BLN) Assay
The GeneSearch™ BLN Assay is a real time Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) assay that detects the presence of breast tumor cell metastasis in lymph nodes through the detection of gene expression markers present in breast tissue, but not in nodal tissue (cell type specific messenger RNA).
Other Names:
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Outcome Measures
Primary Outcome Measures
- To estimate the positive predictive concordance (PPC) between the GeneSearch™ BLN Assay and histology as routinely practiced. [1 week]
Secondary Outcome Measures
- To estimate the positive predictive value (PPV) of the GeneSearch™ BLN Assay as measured against histology that is as accurate as possible in assessing whether a SLN is truly positive. [1 week]
- To gather data on size of metastases (micrometastases versus macrometastases) identified by histology to examine the assay performance for various levels of metastases. [1 week]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pre-operatively established diagnosis of invasive carcinoma of the breast
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Scheduled for axillary sentinel lymph node dissection as per standard of care at the clinical site for newly diagnosed breast cancer patients
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Patients for whom the GeneSearch™ BLN Assay will be used intra-operatively to make a decision for an axillary lymph node dissection
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18 years of age or older
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Female or male
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Willing and able to give informed consent to participate in the study
Exclusion Criteria:
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Previous diagnosis of lymphoma
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Subjects participating in other research studies that would interfere with their full participation in this study
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Patients and/or conditions with 'interfering substances' as listed in the IFU.
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Patients who have had any pre-operative treatment for breast cancer including neoadjuvant and/or hormonal intervention such as aromatase inhibitors or tamoxifen
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 2 | Georgetown University Medical Center | Washington | District of Columbia | United States | 20007 |
| 3 | Morton Plant Hospital | Clearwater | Florida | United States | 33756 |
| 4 | St. Anthony's Hospital | St. Petersburg | Florida | United States | 33705 |
| 5 | Georgia Esoteric and Molecular Labs, LLC | Augusta | Georgia | United States | 30912 |
| 6 | Woman's Hospital | Flowood | Mississippi | United States | 39232 |
Sponsors and Collaborators
- Janssen Diagnostics, LLC
Investigators
- Study Director: Scott U Adams, MS, Ortho-Clinical Diagnostics, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
- Blumencranz P, Whitworth PW, Deck K, Rosenberg A, Reintgen D, Beitsch P, Chagpar A, Julian T, Saha S, Mamounas E, Giuliano A, Simmons R. Scientific Impact Recognition Award. Sentinel node staging for breast cancer: intraoperative molecular pathology overcomes conventional histologic sampling errors. Am J Surg. 2007 Oct;194(4):426-32.
- Julian TB, Blumencranz P, Deck K, Whitworth P, Berry DA, Berry SM, Rosenberg A, Chagpar AB, Reintgen D, Beitsch P, Simmons R, Saha S, Mamounas EP, Giuliano A. Novel intraoperative molecular test for sentinel lymph node metastases in patients with early-stage breast cancer. J Clin Oncol. 2008 Jul 10;26(20):3338-45. doi: 10.1200/JCO.2007.14.0665.
- Veys I, Majjaj S, Salgado R, Noterman D, Schobbens JC, Manouach F, Bourgeois P, Nogaret JM, Larsimont D, Durbecq V. Evaluation of the histological size of the sentinel lymph node metastases using RT-PCR assay: a rapid tool to estimate the risk of non-sentinel lymph node invasion in patients with breast cancer. Breast Cancer Res Treat. 2010 Dec;124(3):599-605. doi: 10.1007/s10549-009-0555-2. Epub 2009 Sep 25.
- GeneSearch BLN Assay PPC Study
- BLN-US-2007.00