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GeneSearch™ Breast Lymph Node (BLN) Assay Post Approval Study

18 Years
Not Enrolling
Breast Cancer

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Trial Information

GeneSearch™ Breast Lymph Node (BLN) Assay Post Approval Study

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

To estimate the positive predictive concordance (PPC) between the GeneSearch™ BLN Assay and histology as routinely practiced.

Outcome Time Frame:

1 week

Safety Issue:


Principal Investigator

Scott U Adams, MS

Investigator Role:

Study Director

Investigator Affiliation:

Ortho-Clinical Diagnostics


United States: Institutional Review Board

Study ID:

GeneSearch BLN Assay PPC Study



Start Date:

December 2007

Completion Date:

July 2010

Related Keywords:

  • Breast Cancer
  • BreastCancer
  • Sentinel Lymph Nodes
  • Metastasis
  • Breast Neoplasms



Cedars-Sinai Medical Center Los Angeles, California  90048
Morton Plant Hospital Clearwater, Florida  33756
Georgetown University Medical Center Washington, District of Columbia  20007
St. Anthony's Hospital St. Petersburg, Florida  33705
Georgia Esoteric and Molecular Labs, LLC Augusta, Georgia  30912
Woman's Hospital Flowood, Mississippi  39232