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

NCT00869674 | Terminated Phase 3

• 2 other identifiers: OCD-200804CBCSG-001a
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 6

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

Conditions

Breast Cancer

Keywords

GeneSearch; Breast cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  9 months

Secondary Outcomes (1)

• 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.

  9 months

Study Arms (2)

Routine pathologic method

NO INTERVENTION

Half of each sentinal lymph node will have rountine pathologic examination as normal practice.

GeneSearch BLN Assay

EXPERIMENTAL

Half of each sentinal lymph node will have GeneSearch BLN testing.

Procedure: GeneSearch™ Breast Lymph Node (BLN) Assay

Interventions

GeneSearch™ Breast Lymph Node (BLN) Assay PROCEDURE

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.

Also known as: GeneSearch, Pathology

GeneSearch BLN Assay

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed previously as breast cancer
• patient scheduled for sentinel lymph node dissection
• years or older
• female or male, and
• able and willing to give consent to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Medical, China: lead

Study Sites (6)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100035, China

Location

Guangdong General Hospital

Guangdong, Guangdong, 510080, China

Location

Second affiliated hospital of Zhongshan University

Guangzhou, Guangdong, China

Location

China Shandong Cancer hospital

Jinan, Shandong, 250117, China

Location

Southwest Hospital

Chongqing, Sichuan, 400038, China

Location

Shanghai Cancer Hospital

Shanghai, 200032, China

Location

Related Publications (23)

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  BACKGROUND

• Turner RR, Weaver DL, Cserni G, Lester SC, Hirsch K, Elashoff DA, Fitzgibbons PL, Viale G, Mazzarol G, Ibarra JA, Schnitt SJ, Giuliano AE. Nodal stage classification for breast carcinoma: improving interobserver reproducibility through standardized histologic criteria and image-based training. J Clin Oncol. 2008 Jan 10;26(2):258-63. doi: 10.1200/JCO.2007.13.0179.

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• Liu YH, Xu FP, Liao N, Li L, Zhang GC, Zhuang HG, Mei P, Xu J, Zhu XL, Luo XL, Kuang LJ. Efficacy of intraoperative GeneSearch Breast Lymph Node (BLN) Assay for breast cancer metastasis detection in sentinel lymph node in Chinese patients. Cancer Sci. 2010 Aug;101(8):1920-4. doi: 10.1111/j.1349-7006.2010.01618.x. Epub 2010 Jan 17.

  PMID: 20557308 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biological Assay

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Yongsheng Wang, MD

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2009
• First Posted: March 26, 2009
• Study Start: February 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: May 30, 2013

Record last verified: 2009-06

Locations

CN (6)