GeneSearch Breast Lymph Node (BLN) Assay Timing Study

January 11, 2016 updated by: Janssen Diagnostics, LLC
This study is designed to collect data about the amount of time required to use the assay in clinical-use conditions.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

233

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 day
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
1 day
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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Diagnostics, LLC

Investigators

  • Study Director: Scott U Adams, MS, Ortho-Clinical Diagnostics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

January 4, 2008

First Submitted That Met QC Criteria

January 4, 2008

First Posted (Estimate)

January 16, 2008

Study Record Updates

Last Update Posted (Estimate)

January 12, 2016

Last Update Submitted That Met QC Criteria

January 11, 2016

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GeneSearch BLN Timing Study
  • BLN-TIMING-2007.00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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