Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Neoplasm Metastasis

Breast Neoplasms

Breast Diseases

Skin Diseases

Half of each sentinal lymph node will have rountine pathologic examination as normal practice.

Half of each sentinal lymph node will have GeneSearch BLN testing.

Each of the sentinal lymph node will be divided in half according to cutting scheme.

Half of the sentinal lymph node will be tested using rountine pathological method as normal practice, half of the node will have GeneSearch BLN testing.

GeneSearch™ Breast Lymph Node (BLN) Assay

Yongsheng Wang, MD

The primary objective of this trial is to compare GeneSearch™ Breast Lymph Node (BLN) Test Kit to permanent pathological section, so as to evaluate the clinical sensitivity and specificity of GeneSearch™ Breast Lymph Node (BLN) Test Kit in detecting axillary sentinel lymph node metastases in breast cancer patients.

The secondary objective of this trial is to evaluate the positive predictive value and negative predictive value of GeneSearch™ Breast Lymph Node (BLN) Test Kit when used in the detection of axillary sentinel lymph node metastases in breast cancer patients.

Prospective and multi-center clinical trial

GeneSearch™ Breast Lymph Node (BLN) Assay China Registration Study

一项比较GeneSearch 乳腺淋巴结（BLN）检测试剂盒和永久病理切片检测乳腺癌患者腋窝前哨淋巴结转移的前瞻性、多中心临床试验 A Prospective and Multi-center Clinical Trial By Comparing GeneSearch™ Breast Lymph Node (BLN) Test Kit To Permanent Pathological Section On Detecting Axillary Sentinel Lymph Node Metastases In Breast Cancer Patients

Johnson & Johnson Medical, China

Patients with previous diagnosis of breast cancer scheduled for sentinel lymph node dissection.

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.

Robert J. Goulet, MD

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

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.

Samples of the tissue homogenate and extracted RNA will be retained and may be used for for further testing.

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

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

Janssen Diagnostics, LLC

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).

Scott U Adams, MS

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

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 title	NCT ID	Conditions	Interventions	Eligibility	Organization
GeneSearch™ Breast Lymph Node (BLN) Assay China Registration Study	NCT00869674	Breast Cancer	GeneSearch™ Bre...	18 Years -	Johnson & Johnson Medical, China
Validation Study Using the GeneSearch BLN Assay to Test Sentinel Lymph Nodes From Patients With Breast Cancer	NCT00551278	Breast Cancer	GeneSearch™ Bre...	18 Years -	Janssen Diagnostics, LLC
GeneSearch Breast Lymph Node (BLN) Assay Timing Study	NCT00595023	Breast Cancer	GeneSearch™ Bre...	18 Years -	Janssen Diagnostics, LLC

Spots Global Cancer Trial Database for genesearch™ breast lymph node (bln) assay