GeneSearch Breast Lymph Node (BLN) Assay Timing Study

Breast Cancer Clinical Trial

Official title:

GeneSearch Breast Lymph Node (BLN) Assay Timing Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00595023
• Other study ID #: GeneSearch BLN Timing Study
• Secondary ID: BLN-TIMING-2007.
• Status: Terminated
• Phase: Phase 4
• First received: January 4, 2008
• Last updated: January 11, 2016
• Start date: December 2007
• Est. completion date: December 2009

Study information

• Verified date: January 2010
• Source: Janssen Diagnostics, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 233
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• GeneSearch™ Breast Lymph Node (BLN) Assay
The GeneSearch™ BLN Assay is a real time Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) assay that detects the presence of breast tumor cell metastasis in lymph nodes through the detection of gene expression markers present in breast tissue, but not in nodal tissue (cell type specific messenger RNA).

Locations

Country	Name	City	State
United States	Georgia Esoteric and Molecular Labs, LLC	Augusta	Georgia
United States	Morton Plant Hospital	Clearwater	Florida
United States	Woman's Hospital	Flowood	Mississippi
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	St. Anthony's Hospital	St. Petersburg	Florida
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Diagnostics, LLC

Country where clinical trial is conducted

United States, 

References & Publications (3)

Blumencranz P, Whitworth PW, Deck K, Rosenberg A, Reintgen D, Beitsch P, Chagpar A, Julian T, Saha S, Mamounas E, Giuliano A, Simmons R. Scientific Impact Recognition Award. Sentinel node staging for breast cancer: intraoperative molecular pathology overcomes conventional histologic sampling errors. Am J Surg. 2007 Oct;194(4):426-32. — View Citation

Julian TB, Blumencranz P, Deck K, Whitworth P, Berry DA, Berry SM, Rosenberg A, Chagpar AB, Reintgen D, Beitsch P, Simmons R, Saha S, Mamounas EP, Giuliano A. Novel intraoperative molecular test for sentinel lymph node metastases in patients with early-stage breast cancer. J Clin Oncol. 2008 Jul 10;26(20):3338-45. doi: 10.1200/JCO.2007.14.0665. — View Citation

Veys I, Majjaj S, Salgado R, Noterman D, Schobbens JC, Manouach F, Bourgeois P, Nogaret JM, Larsimont D, Durbecq V. Evaluation of the histological size of the sentinel lymph node metastases using RT-PCR assay: a rapid tool to estimate the risk of non-sentinel lymph node invasion in patients with breast cancer. Breast Cancer Res Treat. 2010 Dec;124(3):599-605. doi: 10.1007/s10549-009-0555-2. Epub 2009 Sep 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No

External Links

•   Study Sponsor Website