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

Johnson & Johnson (J&J)

Status and phase: Terminated; Phase 3

Conditions: Breast Cancer

Treatments: Procedure: GeneSearch™ Breast Lymph Node (BLN) Assay

Study type: Interventional

Funder types: Industry

Identifiers

NCT00869674

CBCSG-001a

OCD-200804

Details and patient eligibility

About

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

Enrollment: 540 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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540 participants in 2 patient groups

Routine pathologic method

No Intervention group

Description:

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

GeneSearch BLN Assay

Experimental group

Description:

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

Treatment:

Procedure: GeneSearch™ Breast Lymph Node (BLN) Assay