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

NCT00869674 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2013-05-30

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Johnson & Johnson Medical, China

    lead INDUSTRY

Principal Investigators

  • Yongsheng Wang, MD · Shandong Cancer Hospital and Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-10-31
Completion
2009-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00869674 on ClinicalTrials.gov