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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00869674

Enrollment

540

Registered

2009-03-26

Start date

2009-02-28

Completion date

2009-11-30

Last updated

2013-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

GeneSearch, Breast cancer

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

Interventions

PROCEDUREGeneSearch™ 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026