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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Sysmex America, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sysmex America, Inc.
ClinicalTrials.gov Identifier:
NCT01140763
First received: June 3, 2010
Last updated: August 27, 2010
Last verified: August 2010
  Purpose

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 Intervention
Breast Neoplasms
Breast Diseases
Device: Sysmex's 5-blade lymph node cutter

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Tissue Sampling Bias in Histologic Evaluation of Sentinel Lymph Nodes in Breast Cancer

Resource links provided by NLM:


Further study details as provided by Sysmex America, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: August 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with a previous diagnosis of breast cancer scheduled for sentinel lymph node dissection.

Criteria

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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140763

Locations
United States, Pennsylvania
Breast Care Specialist, PC Recruiting
Allentown, Pennsylvania, United States, 18104
Contact: Charlotte Bryk    610-366-7333    cbryk2@yahoo.com   
Principal Investigator: Mark A Gittleman, MD         
Sponsors and Collaborators
Sysmex America, Inc.
  More Information

No publications provided

Responsible Party: Carrie Pineda, Sysmex America, Inc
ClinicalTrials.gov Identifier: NCT01140763     History of Changes
Other Study ID Numbers: Histo-BC-001
Study First Received: June 3, 2010
Last Updated: August 27, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Sysmex America, Inc.:
metastasis

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

ClinicalTrials.gov processed this record on October 23, 2014