Clinical trial NCT00595296: GeneSearch™ Breast Lymph Node (BLN) Assay Post Approval Study
Official title: GeneSearch™ Breast Lymph Node (BLN) Assay Post Approval Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Keywords: BreastCancer
Sentinel Lymph Nodes
Metastasis
Lead sponsor: Janssen Diagnostics, LLC
Sponsor class: INDUSTRY
First posted: 2008-01-16
Enrollment: 461
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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).

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 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

Primary outcomes:
measure: To estimate the positive predictive concordance (PPC) between the GeneSearch™ BLN Assay and histology as routinely practiced.
timeFrame: 1 week
Secondary outcomes:
measure: 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.
timeFrame: 1 week
measure: To gather data on size of metastases (micrometastases versus macrometastases) identified by histology to examine the assay performance for various levels of metastases.
timeFrame: 1 week
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: St. Petersburg
country: United States
facility: St. Anthony's Hospital
state: Florida
city: Augusta
country: United States
facility: Georgia Esoteric and Molecular Labs, LLC
state: Georgia
city: Flowood
country: United States
facility: Woman's Hospital
state: Mississippi
Study officials:
affiliation: Ortho-Clinical Diagnostics, Inc.
name: Scott U Adams, MS
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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.