GeneSearch Breast Lymph Node (BLN) Assay Timing 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: NCT00595023
Recruitment Status : Terminated (GeneSearch™ BLN Assay has been voluntarily withdrawn from the US market.)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 study is designed to collect data about the amount of time required to use the assay in clinical-use conditions.

Condition or disease Intervention/treatment
Breast Cancer Device: GeneSearch™ Breast Lymph Node (BLN) Assay

Detailed Description:
Assay turn-around-time will be collected at sites that are using the GeneSearch BLN Assay for intraoperative testing of sentinel lymph nodes. The sites must be planning to use the assay result to guide the decision to complete an axillary lymph node dissection.

Study Type : Observational
Actual Enrollment : 233 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: GeneSearch Breast Lymph Node (BLN) Assay Timing 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

Group/Cohort Intervention/treatment
All eligible subjects
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 determine, under clinical use conditions, the assay turn-around-time (TAT) from the time of node removal to the report of the assay result to the surgeon. [ Time Frame: 1 day ]
  2. To determine, under clinical use conditions, whether the assay result was or was not received in time ('time for decision' (TFD)) to make an intra-operative decision to proceed to further non-sentinel axillary lymph node dissection. [ Time Frame: 1 day ]
  3. To collect data in relation to other surgical procedures during the SLND/breast surgery to determine if the assay TAT resulted in longer surgery time than would have occurred if the assay had not been used. [ Time Frame: 1 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Intraoperative use of the GeneSearch™ BLN Assay to make a decision for an axillary lymph node dissection in patients with invasive carcinoma of the breast.

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

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): NCT00595023

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.