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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00595296
Recruitment Status : Terminated (GeneSearch™ BLN Assay has been voluntarily withdrawn from the US market.)
First Posted : January 16, 2008
Last Update Posted : January 12, 2016
Information provided by (Responsible Party):
Janssen Diagnostics, LLC

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
Breast Cancer Device: GeneSearch™ Breast Lymph Node (BLN) Assay

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 Type : Observational
Actual Enrollment : 461 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: GeneSearch™ Breast Lymph Node (BLN) Assay Post Approval Study
Study Start Date : December 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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:
  • BLN Assay
  • GeneSearch™ BLN Assay

Primary Outcome Measures :
  1. To estimate the positive predictive concordance (PPC) between the GeneSearch™ BLN Assay and histology as routinely practiced. [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 1 week ]
  2. To gather data on size of metastases (micrometastases versus macrometastases) identified by histology to examine the assay performance for various levels of metastases. [ Time Frame: 1 week ]

Biospecimen Retention:   Samples With DNA
Samples of the lymph node tissue homogenate and RNA extract are collected if the subject gives permission via the informed consent form.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients must have been diagnosed with carcinoma of the breast and be a candidate for lymph node surgery as per each site's standard of care. The patients may be female or male, at least 18 years old, and must meet study inclusion criteria described later in this protocol. Patients receiving pre-operative therapy for breast cancer, such as neoadjuvant therapy and/or hormonal intervention are not eligible to participate in this study.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00595296

United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Florida
Morton Plant Hospital
Clearwater, Florida, United States, 33756
St. Anthony's Hospital
St. Petersburg, Florida, United States, 33705
United States, Georgia
Georgia Esoteric and Molecular Labs, LLC
Augusta, Georgia, United States, 30912
United States, Mississippi
Woman's Hospital
Flowood, Mississippi, United States, 39232
Sponsors and Collaborators
Janssen Diagnostics, LLC
Study Director: Scott U Adams, MS Ortho-Clinical Diagnostics, Inc.

Responsible Party: Janssen Diagnostics, LLC Identifier: NCT00595296     History of Changes
Other Study ID Numbers: GeneSearch BLN Assay PPC Study
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016

Keywords provided by Janssen Diagnostics, LLC:
Sentinel Lymph Nodes