Validation Study Using the GeneSearch BLN Assay to Test Sentinel Lymph Nodes From Patients With Breast Cancer
Study Details
Study Description
Brief Summary
The purpose of this trial is to show adequate assay performance on clinical samples tested in real time at the clinical site.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 Patients with previous diagnosis of breast cancer scheduled for sentinel lymph node dissection. |
Device: GeneSearch™ Breast Lymph Node (BLN) Assay
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.
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Outcome Measures
Primary Outcome Measures
- 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. [1 month]
Secondary Outcome Measures
- A secondary objective will assess the timing and logistical aspects of introducing a real time molecular test within the pathology lab. [1 day]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Previous diagnosis of carcinoma of the breast
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Patient scheduled for sentinel lymph node dissection as per standard of care at the clinical site
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18 years or older
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Female or male, and
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Indiana University Hospital | Indianapolis | Indiana | United States | 46202 |
Sponsors and Collaborators
- Janssen Diagnostics, LLC
Investigators
- Principal Investigator: Robert J. Goulet, MD, Indiana University Cancer Pavilion
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BLN-US-IU-2006.00