Breast Cancer Clinical Trial

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GeneSearch Breast Lymph Node (BLN) Assay Timing Study

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Summary

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

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Full 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.

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Eligibility 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 GeneSearchâ„¢ 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 is for people with:

Breast Cancer

Estimated Enrollment:

233

Study ID:

NCT00595023

Recruitment Status:

Terminated

Sponsor:

Janssen Diagnostics, LLC

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There are 6 Locations for this study

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

233

Study ID:

NCT00595023

Recruitment Status:

Terminated

Sponsor:


Janssen Diagnostics, LLC

How clear is this clinincal trial information?

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