Status:
TERMINATED
GeneSearch™ Breast Lymph Node (BLN) Assay China Registration Study
Lead Sponsor:
Johnson & Johnson Medical, China
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 GeneSear...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT00869674
Start Date
February 1 2009
End Date
November 1 2009
Last Update
May 30 2013
Active Locations (6)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100035
2
Guangdong General Hospital
Guangdong, Guangdong, China, 510080
3
Second affiliated hospital of Zhongshan University
Guangzhou, Guangdong, China
4
China Shandong Cancer hospital
Jinan, Shandong, China, 250117