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

This study has been terminated.
(Investigational products has been suspended from the US market)
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Medical, China
ClinicalTrials.gov Identifier:
NCT00869674
First received: March 25, 2009
Last updated: May 29, 2013
Last verified: June 2009

March 25, 2009
May 29, 2013
February 2009
October 2009   (final data collection date for primary 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. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00869674 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
GeneSearch™ Breast Lymph Node (BLN) Assay China Registration Study
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

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

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Breast Cancer
Procedure: GeneSearch™ Breast Lymph Node (BLN) Assay

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.

Other Names:
  • GeneSearch
  • Pathology
  • No Intervention: Routine pathologic method
    Half of each sentinal lymph node will have rountine pathologic examination as normal practice.
  • Experimental: GeneSearch BLN Assay
    Half of each sentinal lymph node will have GeneSearch BLN testing.
    Intervention: Procedure: GeneSearch™ Breast Lymph Node (BLN) Assay

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
540
November 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00869674
OCD-200804, CBCSG-001a
No
Johnson & Johnson Medical, China
Johnson & Johnson Medical, China
Not Provided
Principal Investigator: Yongsheng Wang, MD Shandong Cancer Hospital
Johnson & Johnson Medical, China
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP