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GeneSearch Breast Lymph Node (BLN) Assay Timing Study

Phase 4
18 Years
Not Enrolling
Breast Cancer

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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 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

Type of Study:


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:


Principal Investigator

Scott U Adams, MS

Investigator Role:

Study Director

Investigator Affiliation:

Ortho-Clinical Diagnostics


United States: Institutional Review Board

Study ID:

GeneSearch BLN Timing Study



Start Date:

December 2007

Completion Date:

July 2010

Related Keywords:

  • Breast Cancer
  • Sentinel lymph node
  • Metastasis
  • Breast Neoplasms



Cedars-Sinai Medical CenterLos Angeles, California  90048
Morton Plant HospitalClearwater, Florida  33756
Georgetown University Medical CenterWashington, District of Columbia  20007
St. Anthony's HospitalSt. Petersburg, Florida  33705
Georgia Esoteric and Molecular Labs, LLCAugusta, Georgia  30912
Woman's HospitalFlowood, Mississippi  39232