GeneSearch Breast Lymph Node (BLN) Assay Timing Study
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer
Both
Breast Cancer
Trial Information
GeneSearch Breast Lymph Node (BLN) Assay Timing Study
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome 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.
Outcome Time Frame:
1 day
Safety Issue:
No
Principal Investigator
Scott U Adams, MS
Investigator Role:
Study Director
Investigator Affiliation:
Ortho-Clinical Diagnostics
Authority:
United States: Institutional Review Board
Study ID:
GeneSearch BLN Timing Study
NCT ID:
NCT00595023
Start Date:
December 2007
Completion Date:
July 2010
Related Keywords:
- Breast Cancer
- Sentinel lymph node
- Metastasis
- Breast Neoplasms
Name | Location |
|---|---|
| Cedars-Sinai Medical Center | Los Angeles, California 90048 |
| Morton Plant Hospital | Clearwater, Florida 33756 |
| Georgetown University Medical Center | Washington, District of Columbia 20007 |
| St. Anthony's Hospital | St. Petersburg, Florida 33705 |
| Georgia Esoteric and Molecular Labs, LLC | Augusta, Georgia 30912 |
| Woman's Hospital | Flowood, Mississippi 39232 |
