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General |
Study Status |
Other |
Application Number / Requirement Number |
P060017 / PAS001 |
Date Original Protocol Accepted |
10/29/2007
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Date Current Protocol Accepted |
10/29/2007
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Study Name |
PPC Study
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Device Name |
GENESEARCH BREAST LYMPH NODE(BLN) ASSAY
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General Study Protocol Parameters |
Study Design |
Cross-Sectional Study
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Data Source |
New Data Collection
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Comparison Group |
Objective Performance Criterion
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Analysis Type |
Analytical
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Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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Detailed Study Protocol Parameters |
Study Objectives |
The post-approval study is a clinical study to estimate the positive predictive concordance between the breast lymph node assay and histology as routinely practiced i.e., routine hematoxylene and eosin histology of sentinel lymph node(s), and when available, routine histology of non-sentinel axillary lymph nodes. The positive predictive concordance value is defined as the proportion of breast lymph node assay positive subjects with histologically detectable breast cancer metastases.
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Study Population |
Study Population: Breast cancer patients. Indication: The device is indicated as an in vitro diagnostic test for the rapid detection of greater than 0.2 mm metastases in nodul tissue removed from the sentinel lymph nodes biopsies of breast cancer patients.
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Sample Size |
1,000 female or male patients to include a minimum of 246 breast lymph node positive patients, 4 sites
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Key Study Endpoints |
The primary endpoint is the efficacy endpoint as measured as a metric that uses the less thorough reference. The metric is the positive predictive concordance between the breast lymph node assay and histology as routinely practiced i.e., routine hematoxylene and eosin, histology of sentinel lymph node(s), and when available, routine histology of non-sentinel axillary lymph nodes.
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Follow-up Visits and Length of Follow-up |
Follow-up was not required for this study.
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