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

NCT01140763 | Unknown DMC

• 1 other identifier: Histo-BC-001
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Breast Diseases

Keywords

metastasis

Outcome Measures

Primary Outcomes (1)

• Prospectively assess the agreement of histopathology results on tissue sections taken from different slices of SLNs removed using standard SLN biopsy procedures.

  9 months

Study Arms (1)

Sysmex's 5-blade cutter.

Device: Sysmex's 5-blade lymph node cutter

Interventions

Sysmex's 5-blade lymph node cutter DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Male or female
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sysmex America, Inc.: lead

Study Sites (1)

Breast Care Specialist, PC

Allentown, Pennsylvania, 18104, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Breast Diseases; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 3, 2010
• First Posted: June 9, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2012
• Last Updated: August 30, 2010

Record last verified: 2010-08

Locations

US (1)