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


N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

1 month

Safety Issue:

No

Principal Investigator

Robert J. Goulet, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University Cancer Pavilion

Authority:

United States: Institutional Review Board

Study ID:

BLN-US-IU-2006.00

NCT ID:

NCT00551278

Start Date:

October 2007

Completion Date:

December 2009

Related Keywords:

  • Breast Cancer
  • sentinel lymph node
  • metastasis
  • molecular pathology
  • Breast Neoplasms

Name

Location
Indiana University Hospital Indianapolis, Indiana  46202