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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
540
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.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Guangdong General Hospital
Guangdong, Guangdong, China
Second affiliated hospital of Zhongshan University
Guangzhou, Guangdong, China
China Shandong Cancer hospital
Jinan, Shandong, China
Southwest Hospital
Chongqing, Sichuan, China
Shanghai Cancer Hospital
Shanghai, China
To compare GeneSearch™ BLN Test Kit to permanent pathological section to evaluate the clinical sensitivity and specificity of GeneSearch™ BLN Test Kit in detecting axillary sentinel lymph node metastases in breast cancer patients.
Time frame: 9 months
To evaluate the positive predictive value and negative predictive value of GeneSearch™ BLN Test Kit when used in the detection of axillary sentinel lymph node metastases in breast cancer patients.
Time frame: 9 months
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