GeneSearch Breast Lymph Node (BLN) Assay Timing Study

Terminated

• Conditions: Breast Cancer
• Interventions: Device: GeneSearch™ Breast Lymph Node (BLN) Assay

• Registration Number: NCT00595023
• Lead Sponsor: Janssen Diagnostics, LLC

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.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-04
• Study First Submitted QC: 2008-01-04
• Study First Posted: 2008-01-16
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-01
• Last Update Submitted: 2016-01-11
• Last Update Posted: 2016-01-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 233

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	GeneSearch™ Breast Lymph Node (BLN) Assay	All eligible subjects

Primary Outcome Measures

Name	Time	Method
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.	1 day
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.	1 day
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.	1 day

Trial Locations

Locations (6)

Georgia Esoteric and Molecular Labs, LLC; 🇺🇸 Augusta, Georgia, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

St. Anthony's Hospital; 🇺🇸 St. Petersburg, Florida, United States

Woman's Hospital; 🇺🇸 Flowood, Mississippi, United States

Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States

Morton Plant Hospital; 🇺🇸 Clearwater, Florida, United States