GeneSearch™ Breast Lymph Node (BLN) Assay Post Approval Study - Full Text View

Sponsored by:	Veridex, LLC
Information provided by:	Veridex, LLC
ClinicalTrials.gov Identifier:	NCT00595296

Purpose

This post-approval study is designed to determine the performance of the FDA-approved GeneSearch™ BLN Assay when compared to the site's standard of care permanent section histological evaluation, and when compared to more extensive histological evaluation when the assay is being used by clinicians to make surgical decisions on complete axillary dissections (ALND).

Condition	Intervention
Breast Cancer	Device: GeneSearch™ Breast Lymph Node (BLN) Assay

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	GeneSearch™ Breast Lymph Node (BLN) Assay Post Approval Study

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by Veridex, LLC:

Primary Outcome Measures:

To estimate the positive predictive concordance (PPC) between the GeneSearch™ BLN Assay and histology as routinely practiced. [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To estimate the positive predictive value (PPV) of the GeneSearch™ BLN Assay as measured against histology that is as accurate as possible in assessing whether a SLN is truly positive. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
To gather data on size of metastases (micrometastases versus macrometastases) identified by histology to examine the assay performance for various levels of metastases. [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Samples of the lymph node tissue homogenate and RNA extract are collected if the subject gives permission via the informed consent form.

Estimated Enrollment:	1000
Study Start Date:	December 2007
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 All eligible patients.	Device: GeneSearch™ Breast Lymph Node (BLN) Assay 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).

Detailed Description:

The primary objective of this clinical study is to gather data to estimate the positive predictive concordance (PPC) between the GeneSearch™ BLN Assay and histology as routinely practiced, i.e., routine H&E histology of sentinel lymph node(s) (SLN) and, when available, routine histology of non-sentinel axillary lymph nodes (ALN). This study will provide information on the assay that will augment the performance data gained in pre-market validation studies. In addition, with the assay being used for ALND decision-making, the metastatic status of the non-sentinel axillary nodes can be taken into account in the performance measures, i.e., if the patient's sentinel or non-sentinel nodes are histologically positive, the patient will be considered positive for the primary comparison to the assay results.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients must have been diagnosed with carcinoma of the breast and be a candidate for lymph node surgery as per each site's standard of care. The patients may be female or male, at least 18 years old, and must meet study inclusion criteria described later in this protocol. Patients receiving pre-operative therapy for breast cancer, such as neoadjuvant therapy and/or hormonal intervention are not eligible to participate in this study.

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 GeneSearch™ 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
Willing and able to give informed consent to participate in the study

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595296

Contacts

Contact: Scott U Adams, MS

908-541-5854

sadams17@its.jnj.com

Locations

United States, Florida
Morton Plant Hospital	Recruiting
Clearwater, Florida, United States, 33756
Principal Investigator: Peter W Blumencranz, MD
United States, Georgia
Georgia Esoteric and Molecular Labs, LLC	Recruiting
Augusta, Georgia, United States, 30912
Principal Investigator: Nidia Messias, MD
United States, Mississippi
Woman's Hospital	Recruiting
Flowood, Mississippi, United States, 39232
Principal Investigator: Phillip B Ley, MD
United States, Pennsylvania
DSI of Bucks County	Recruiting
Bensalem, Pennsylvania, United States, 19020
Principal Investigator: Beth DuPree, MD

Sponsors and Collaborators

Veridex, LLC

Investigators

Study Director:

Scott U Adams, MS

Ortho-Clinical Diagnostics

More Information

Publications:

Julian TB, Blumencranz P, Deck K, Whitworth P, Berry DA, Berry SM, Rosenberg A, Chagpar AB, Reintgen D, Beitsch P, Simmons R, Saha S, Mamounas EP, Giuliano A. Novel intraoperative molecular test for sentinel lymph node metastases in patients with early-stage breast cancer. J Clin Oncol. 2008 Jul 10;26(20):3338-45.

Blumencranz P, Whitworth PW, Deck K, Rosenberg A, Reintgen D, Beitsch P, Chagpar A, Julian T, Saha S, Mamounas E, Giuliano A, Simmons R. Scientific Impact Recognition Award. Sentinel node staging for breast cancer: intraoperative molecular pathology overcomes conventional histologic sampling errors. Am J Surg. 2007 Oct;194(4):426-32.

Responsible Party:	Ortho-Clinical Diagnostics ( Scott Adams, Clinical Science Manager )
Study ID Numbers:	GeneSearch BLN Assay PPC Study, BLN-US-2007.00
Study First Received:	January 4, 2008
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00595296 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Veridex, LLC:

BreastCancer
Sentinel Lymph Nodes
Metastasis

Study placed in the following topic categories:

Skin Diseases
Neoplasm Metastasis
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on July 02, 2009