Clinical trial NCT00595023: GeneSearch Breast Lymph Node (BLN) Assay Timing Study
Official title: GeneSearch Breast Lymph Node (BLN) Assay Timing Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Keywords: Sentinel lymph node
Metastasis
Lead sponsor: Janssen Diagnostics, LLC
Sponsor class: INDUSTRY
First posted: 2008-01-16
Enrollment: 233
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: Intraoperative use of the GeneSearch™ BLN Assay to make a decision for an axillary lymph node dissection in patients with invasive carcinoma of the breast.

Brief summary: This study is designed to collect data about the amount of time required to use the assay in clinical-use conditions.

Detailed description: Assay turn-around-time will be collected at sites that are using the GeneSearch BLN Assay for intraoperative testing of sentinel lymph nodes. The sites must be planning to use the assay result to guide the decision to complete an axillary lymph node dissection.

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

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 determine, under clinical use conditions, the assay turn-around-time (TAT) from the time of node removal to the report of the assay result to the surgeon.
timeFrame: 1 day
measure: To determine, under clinical use conditions, whether the assay result was or was not received in time ('time for decision' (TFD)) to make an intra-operative decision to proceed to further non-sentinel axillary lymph node dissection.
timeFrame: 1 day
measure: To collect data in relation to other surgical procedures during the SLND/breast surgery to determine if the assay TAT resulted in longer surgery time than would have occurred if the assay had not been used.
timeFrame: 1 day
Secondary outcomes:
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: 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.
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.