GeneSearch Breast Lymph Node (BLN) Assay Timing Study

Janssen (J&J Innovative Medicine)

Status: Terminated

Conditions: Breast Cancer

Treatments: Device: GeneSearch™ Breast Lymph Node (BLN) Assay

Study type: Observational

Funder types: Industry

Identifiers

NCT00595023

GeneSearch BLN Timing Study

BLN-TIMING-2007.00

Details and patient eligibility

About

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

Full 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.

Enrollment: 233 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

233 participants in 1 patient group

1

Description:

All eligible subjects

Treatment:

Device: GeneSearch™ Breast Lymph Node (BLN) Assay