Clinical trial NCT00869674: GeneSearch™ Breast Lymph Node (BLN) Assay China Registration Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: GeneSearch
Breast cancer
Lead sponsor: Johnson & Johnson Medical, China
Sponsor class: INDUSTRY
First posted: 2009-03-26
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 9 months
Secondary outcomes:
measure: 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.
timeFrame: 9 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Guangdong
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Second affiliated hospital of Zhongshan University
state: Guangdong
city: Jinan
country: China
facility: China Shandong Cancer hospital
state: Shandong
city: Chongqing
country: China
facility: Southwest Hospital
state: Sichuan
city: Shanghai
country: China
facility: Shanghai Cancer Hospital
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: Yongsheng Wang, MD
role: PRINCIPAL_INVESTIGATOR
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