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
18 Years
N/A
Both
Breast Cancer
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Outcome 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.
Outcome Time Frame:
9 months
Safety Issue:
No
Principal Investigator
Yongsheng Wang, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Shandong Cancer Hospital
Authority:
China: Food and Drug Administration
Study ID:
OCD-200804
NCT ID:
NCT00869674
Start Date:
February 2009
Completion Date:
November 2009
Related Keywords:
- Breast Cancer
- GeneSearch
- Breast cancer
- Breast Neoplasms
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