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

NCT00551278 | Completed

• 1 other identifier: BLN-US-IU-2006.00
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

sentinel lymph node; metastasis; molecular pathology

Outcome Measures

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.

  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.

  1 day

Study Arms (1)

1

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

Device: GeneSearch™ Breast Lymph Node (BLN) Assay

Interventions

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Janssen Diagnostics, LLC: lead

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Biological Assay

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Robert J. Goulet, MD

  Indiana University Cancer Pavilion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2007
• First Posted: October 30, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 12, 2016

Record last verified: 2016-01

Locations

US (1)