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Completed

NCT Number: NCT00551278

Validation Study Using the GeneSearch BLN Assay to Test Sentinel Lymph Nodes From Patients With Breast Cancer

The purpose of this trial is to show adequate assay performance on clinical samples tested in real time at the clinical site.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

About this study

This study will determine the sensitivity, specificity, negative predictive value, and positive predictive value of the GeneSearch™ BLN Assay in patient samples by comparing its performance to that of the current methods -- permanent section Hematoxylin and Eosin (H&E) staining with IHC. Additional marker testing using probes associated with nodal metastases may be used in the assay performance calculations. The observed performance measures will be compared to those obtained in the larger U.S. registration trial to show that there are no differences in the assay's performance.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previous diagnosis of carcinoma of the breast
  • Patient scheduled for sentinel lymph node dissection as per standard of care at the clinical site
  • 18 years or older
  • Female or male, and
  • Able and willing to give consent to participate in the study

Exclusion criteria

  • Patients taking part in other research studies that would interfere with their full participation in this study

Treatment and study plan

GeneSearch™ Breast Lymph Node (BLN) Assay

Device

For in vitro diagnostic use only.

The GeneSearch™ Breast Lymph Node (BLN) Assay is a qualitative, in vitro diagnostic test for the rapid detection of greater than 0.2 mm metastases in nodal tissue removed from sentinel lymph node biopsies of breast cancer patients. Results from the assay can be used to guide the intra-operative or post-operative decision to remove additional lymph nodes.

Post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using the Veridex lymph node cutting scheme, is required.

Primary outcomes

  1. The study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the GeneSearch™ BLN Assay by comparing its performance to permanent section Hematoxylin and Eosin (H&E) staining with IHC.

    Time frame: 1 month

Secondary outcomes

  1. A secondary objective will assess the timing and logistical aspects of introducing a real time molecular test within the pathology lab.

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Janssen Diagnostics, LLC

Industry

Registry information

Official study title

GeneSearch™ Breast Lymph Node (BLN) Assay for Molecular Testing Protocol

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 30, 2007
Registry last updated
Jan 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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