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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
  Purpose

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


Condition Intervention Phase
Breast Cancer
Procedure: GeneSearch™ Breast Lymph Node (BLN) Assay
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Medical, China:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 540
Study Start Date: February 2009
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869674

Locations
China, Beijing
Beijing Cancer Hospital
Beijing, Beijing, China, 100035
China, Guangdong
Guangdong General Hospital
Guangdong, Guangdong, China, 510080
Second affiliated hospital of Zhongshan University
Guangzhou, Guangdong, China
China, Shandong
China Shandong Cancer hospital
Jinan, Shandong, China, 250117
China, Sichuan
Southwest Hospital
Chongqing, Sichuan, China, 400038
China
Shanghai Cancer Hospital
Shanghai, China, 200032
Sponsors and Collaborators
Johnson & Johnson Medical, China
Investigators
Principal Investigator: Yongsheng Wang, MD Shandong Cancer Hospital
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johnson & Johnson Medical, China
ClinicalTrials.gov Identifier: NCT00869674     History of Changes
Other Study ID Numbers: OCD-200804, CBCSG-001a
Study First Received: March 25, 2009
Last Updated: May 29, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Johnson & Johnson Medical, China:
GeneSearch
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014