NCT00869674

GeneSearch™ Breast Lymph Node (BLN) Assay China Registration Study

一项比较GeneSearch 乳腺淋巴结（BLN）检测试剂盒和永久病理切片检测乳腺癌患者腋窝前哨淋巴结转移的前瞻性、多中心临床试验 A Prospective and Multi-center Clinical Trial By Comparing GeneSearch™ Breast Lymph Node (BLN) Test Kit To Permanent Pathological Section On Detecting Axillary Sentinel Lymph Node Metastases In Breast Cancer Patients

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 540 (actual)
• Sponsor: Johnson & Johnson Medical, China · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this trial is to compare GeneSearch™ Breast Lymph Node (BLN) Test Kit to permanent pathological section, so as to evaluate the clinical sensitivity and specificity of GeneSearch™ Breast Lymph Node (BLN) Test Kit in detecting axillary sentinel lymph node metastases in breast cancer patients. The secondary objective of this trial is to evaluate the positive predictive value and negative predictive value of GeneSearch™ Breast Lymph Node (BLN) Test Kit when used in the detection of axillary sentinel lymph node metastases in breast cancer patients. Prospective and multi-center clinical trial

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	GeneSearch™ Breast Lymph Node (BLN) Assay	Each of the sentinal lymph node will be divided in half according to cutting scheme. Half of the sentinal lymph node will be tested using rountine pathological method as normal practice, half of the node will have GeneSearch BLN testing.

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-10-01
• Completion: 2009-11-01
• First posted: 2009-03-26
• Last updated: 2013-05-30

Locations

6 sites across 1 country: China