GeneSearch Breast Lymph Node (BLN) Assay Timing Study
Status: | Terminated |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | December 2007 |
End Date: | December 2009 |
This study is designed to collect data about the amount of time required to use the assay in
clinical-use conditions.
clinical-use conditions.
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.
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.
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 GeneSearchâ„¢ 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
We found this trial at
6
sites
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
Washington, District of Columbia 20007
(202) 687-7695
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Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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