GeneSearch Breast Lymph Node (BLN) Assay Timing Study

NCT00595023 | Terminated

• 2 other identifiers: GeneSearch BLN Timing StudyBLN-TIMING-2007.00
• Study Type: observational
• Target: 233
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Breast Cancer

Keywords

Sentinel lymph node; Metastasis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

1

All eligible subjects

Device: GeneSearch™ Breast Lymph Node (BLN) Assay

Interventions

GeneSearch™ Breast Lymph Node (BLN) Assay DEVICE

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).

Also known as: BLN Assay, GeneSearch™ BLN Assay

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Intraoperative use of the GeneSearch™ BLN Assay to make a decision for an axillary lymph node dissection in patients with invasive carcinoma of the breast.

You may qualify if:

• 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
• years of age or older
• Female or male

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Diagnostics, LLC: lead

Study Sites (6)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

St. Anthony's Hospital

St. Petersburg, Florida, 33705, United States

Location

Georgia Esoteric and Molecular Labs, LLC

Augusta, Georgia, 30912, United States

Location

Woman's Hospital

Flowood, Mississippi, 39232, United States

Location

Related 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. doi: 10.1016/j.amjsurg.2007.07.008.

  PMID: 17826050 BACKGROUND

• 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.

  PMID: 19779817 BACKGROUND

• 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.

  PMID: 18612150 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Biological Assay

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Scott U Adams, MS

  Ortho-Clinical Diagnostics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2008
• First Posted: January 16, 2008
• Study Start: December 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 12, 2016

Record last verified: 2010-01

Locations

US (6)