NCT00595296

Brief Summary

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
461

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

2 years

First QC Date

January 4, 2008

Last Update Submit

January 11, 2016

Conditions

Breast Cancer

Keywords

BreastCancerSentinel Lymph NodesMetastasis

Outcome Measures

Primary Outcomes (1)

  • To estimate the positive predictive concordance (PPC) between the GeneSearch™ BLN Assay and histology as routinely practiced.

    1 week

Secondary Outcomes (2)

  • 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.

    1 week

  • To gather data on size of metastases (micrometastases versus macrometastases) identified by histology to examine the assay performance for various levels of metastases.

    1 week

Study Arms (1)

1

All eligible patients.

Device: GeneSearch™ Breast Lymph Node (BLN) Assay

Interventions

GeneSearch™ Breast Lymph Node (BLN) AssayDEVICE

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).

Also known as: BLN Assay, GeneSearch™ BLN Assay
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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
  • years of age or older
  • Female or male
  • Willing and able to give informed consent to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

St. Anthony's Hospital

St. Petersburg, Florida, 33705, United States

Location

Georgia Esoteric and Molecular Labs, LLC

Augusta, Georgia, 30912, United States

Location

Woman's Hospital

Flowood, Mississippi, 39232, United States

Location

Related Publications (3)

  • 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. doi: 10.1016/j.amjsurg.2007.07.008.

    PMID: 17826050BACKGROUND

  • 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. doi: 10.1200/JCO.2007.14.0665.

    PMID: 18612150BACKGROUND

  • Veys I, Majjaj S, Salgado R, Noterman D, Schobbens JC, Manouach F, Bourgeois P, Nogaret JM, Larsimont D, Durbecq V. Evaluation of the histological size of the sentinel lymph node metastases using RT-PCR assay: a rapid tool to estimate the risk of non-sentinel lymph node invasion in patients with breast cancer. Breast Cancer Res Treat. 2010 Dec;124(3):599-605. doi: 10.1007/s10549-009-0555-2. Epub 2009 Sep 25.

    PMID: 19779817BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Interventions

Biological Assay

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Scott U Adams, MS

    Ortho-Clinical Diagnostics, Inc.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 4, 2008

First Posted

January 16, 2008

Study Start

December 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations

US(6)