GeneSearch™ Breast Lymph Node (BLN) Assay Post Approval Study

Breast Cancer Clinical Trial

Official title:

GeneSearch™ Breast Lymph Node (BLN) Assay Post Approval Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00595296
• Other study ID #: GeneSearch BLN Assay PPC Study
• Secondary ID: BLN-US-2007.00
• Status: Terminated
• Phase: N/A
• First received: January 4, 2008
• Last updated: January 11, 2016
• Start date: December 2007
• Est. completion date: December 2009

Study information

• Verified date: January 2016
• Source: Janssen Diagnostics, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 461
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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).

Locations

Country	Name	City	State
United States	Georgia Esoteric and Molecular Labs, LLC	Augusta	Georgia
United States	Morton Plant Hospital	Clearwater	Florida
United States	Woman's Hospital	Flowood	Mississippi
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	St. Anthony's Hospital	St. Petersburg	Florida
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Diagnostics, LLC

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the positive predictive concordance (PPC) between the GeneSearch™ BLN Assay and histology as routinely practiced.		1 week	No
Secondary	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	No
Secondary	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	No