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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: GeneSearch™ Breast Lymph Node (BLN) Assay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed previously as breast cancer patient scheduled for sentinel lymph node dissection 18 years or older female or male, and able and willing to give consent to participate in the study Exclusion Criteria: Patients taking part in other research studies that would interfere with their full participation in this study, or Prior sentinel or partial axillary lymphadenectomy on the same body side

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine pathologic method<br>Half of each sentinal lymph node will have rountine pathologic examination as normal practice. | |
| Experimental: GeneSearch BLN Assay<br>Half of each sentinal lymph node will have GeneSearch BLN testing. | Procedure: GeneSearch™ Breast Lymph Node (BLN) Assay<br>* 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.<br>* Other names: Pathology;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GeneSearch, Breast cancer