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.

Brief 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.

Condition or disease Intervention/treatment
Breast Neoplasms Breast Diseases Device: Sysmex's 5-blade lymph node cutter

Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Tissue Sampling Bias in Histologic Evaluation of Sentinel Lymph Nodes in Breast Cancer
Study Start Date : August 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Sysmex's 5-blade cutter. 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.

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with a previous diagnosis of breast cancer scheduled for sentinel lymph node dissection.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01140763

United States, Pennsylvania
Breast Care Specialist, PC Recruiting
Allentown, Pennsylvania, United States, 18104
Contact: Charlotte Bryk    610-366-7333   
Principal Investigator: Mark A Gittleman, MD         
Sponsors and Collaborators
Sysmex America, Inc.

Responsible Party: Carrie Pineda, Sysmex America, Inc Identifier: NCT01140763     History of Changes
Other Study ID Numbers: Histo-BC-001
First Posted: June 9, 2010    Key Record Dates
Last Update Posted: August 30, 2010
Last Verified: August 2010

Keywords provided by Sysmex America, Inc.:

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases