GeneSearch Breast Lymph Node (BLN) Assay Timing Study

• Sponsor: Janssen Diagnostics, LLC (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00595023
• Collaborator: (none)
• Enrollment: 233
• Locations: 6
• Duration (Months): 24
• Patients Per Site: 38.8
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Device: GeneSearch™ Breast Lymph Node (BLN) Assay

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 233 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: GeneSearch Breast Lymph Node (BLN) Assay Timing Study
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm

Intervention/Treatment

1 All eligible subjects

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).; Other Names: BLN Assay GeneSearch™ BLN Assay

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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]

3. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
2	Georgetown University Medical Center	Washington	District of Columbia	United States	20007
3	Morton Plant Hospital	Clearwater	Florida	United States	33756
4	St. Anthony's Hospital	St. Petersburg	Florida	United States	33705
5	Georgia Esoteric and Molecular Labs, LLC	Augusta	Georgia	United States	30912
6	Woman's Hospital	Flowood	Mississippi	United States	39232

Sponsors and Collaborators

• Janssen Diagnostics, LLC

Investigators

• Study Director: Scott U Adams, MS, Ortho-Clinical Diagnostics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Janssen Diagnostics, LLC
• ClinicalTrials.gov Identifier: NCT00595023
• Other Study ID Numbers: GeneSearch BLN Timing Study; BLN-TIMING-2007.00
• First Posted: Jan 16, 2008
• Last Update Posted: Jan 12, 2016
• Last Verified: Jan 1, 2010

• Keywords provided by Janssen Diagnostics, LLC: Sentinel lymph node; Metastasis

Study Results

No Results Posted as of Jan 12, 2016