MedTrace Logo

Clinical Evaluation of Tissue Sampling Bias in Histologic Evaluation of Sentinel Lymph Nodes in Breast Cancer

NCT01140763 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2010-08-30

No results posted yet for this study

Summary

This is a study to evaluate the incidence of sampling bias during pathologic assessment of sentinel lymph nodes (SLN) when they are cut at a certain thickness (1 mm) and the tissue slices are completely analyzed by histopathology (at 200 µm sections). The sponsor and investigators would like to determine how often small cancer deposits are present in one slice but not the other. The data will provide an empirical estimate of the incidence of tissue sampling bias inherent in using different tissue sections for analysis. The data will also show how varying degrees of detail in evaluating the sentinel lymph nodes (SLN) with histopathology methods will impact the degree of agreement.

Conditions

  • Breast Neoplasms
  • Breast Diseases

Interventions

DEVICE

Sysmex's 5-blade lymph node cutter

A maximum of 3 dissected sentinel lymph nodes (SLN) per subject will be included in this study. Lymph nodes will be sliced at 1 mm intervals with Sysmex's 5-blade lymph node cutter. Alternate slices will be allocated to either "reference" histopathology or "test" histopathology. Three serial sections will be cut every 200 µm (level): the 1st section per level for hematoxylin \& eosin (H\&E), the middle section of the 3rd level for Immunohistochemistry (IHC)(pan- cytokeratin antibody clone AE1/AE3). All other sections will be blanks in case further analysis is needed.

Sponsors & Collaborators

  • Sysmex America, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-12-31
Completion
2012-03-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01140763 on ClinicalTrials.gov