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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01140763
Recruitment Status : Unknown
Verified August 2010 by Sysmex America, Inc..
Recruitment status was:  Recruiting
First Posted : June 9, 2010
Last Update Posted : August 30, 2010
Information provided by:
Sysmex America, Inc.

June 3, 2010
June 9, 2010
August 30, 2010
August 2010
December 2011   (Final data collection date for primary outcome measure)
Prospectively assess the agreement of histopathology results on tissue sections taken from different slices of SLNs removed using standard SLN biopsy procedures. [ Time Frame: 9 months ]
Same as current
Complete list of historical versions of study NCT01140763 on Archive Site
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Clinical Evaluation of Tissue Sampling Bias in Histologic Evaluation of Sentinel Lymph Nodes in Breast Cancer
Tissue Sampling Bias in Histologic Evaluation of Sentinel Lymph Nodes in Breast Cancer
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.
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Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample
Patients with a previous diagnosis of breast cancer scheduled for sentinel lymph node dissection.
  • Breast Neoplasms
  • Breast Diseases
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.
Sysmex's 5-blade cutter.
Intervention: Device: Sysmex's 5-blade lymph node cutter
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
March 2012
December 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female
  • 18 years of age or older
  • Diagnosed pre-surgically with T1 or T2 breast cancer and scheduled for surgery including sentinel lymph node dissection
  • Subjects (or the subject's legal representative) who have read, understood (to the best of their ability) and signed the informed consent form.

Exclusion Criteria:

  • Subjects diagnosed pre-surgically with large or locally advanced (T3 & T4) breast cancer
  • Pregnant subjects, confirmed by interview with either subject or treating physician
  • Subjects diagnosed with inflammatory breast cancer
  • Subjects diagnosed with ductal carcinoma in situ (DCIS) when breast conservation is to be done
  • Subjects with clinically suspicious, palpable axillary lymph nodes
  • Subjects previously treated for or previously diagnosed with another type of invasive cancer. Subjects with skin cancer (basal cell and squamous cell carcinoma) may be included, except for subjects diagnosed with melanoma
  • Subjects who have received pre-operative systemic therapy
  • Subjects who are incapable of providing written informed consent
  • Subjects who have been judged to be an inappropriate candidate by any medical care provider (e.g., surgeon, oncologist or pathologist).
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Carrie Pineda, Sysmex America, Inc
Sysmex America, Inc.
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Sysmex America, Inc.
August 2010