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GeneSearch Breast Lymph Node (BLN) Assay Timing Study

This study has suspended participant recruitment.
(GeneSearch™ BLN Assay has been voluntarily withdrawn from the US market.)
Sponsor:
Information provided by:
Veridex, LLC
ClinicalTrials.gov Identifier:
NCT00595023
First received: January 4, 2008
Last updated: January 7, 2010
Last verified: January 2010
History of Changes
  Purpose

This study is designed to collect data about the amount of time required to use the assay in clinical-use conditions.


Condition Intervention Phase
Breast Cancer
 Device: GeneSearch™ Breast Lymph Node (BLN) Assay
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Veridex, LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: December 2007
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00595023

Locations
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
Veridex, LLC
Investigators
Study Director: Scott U Adams, MS Ortho-Clinical Diagnostics
  More Information

Additional Information:
Study Sponsor Website  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Scott Adams, Clinical Science Manager, Ortho-Clinical Diagnostics
ClinicalTrials.gov Identifier: NCT00595023     History of Changes
Other Study ID Numbers: GeneSearch BLN Timing Study, BLN-TIMING-2007.00
Study First Received: January 4, 2008
Last Updated: January 7, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Veridex, LLC:
Sentinel lymph node
Metastasis

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013