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Trial Title:
Clinical Evaluation of Tissue Sampling Bias in Histologic Evaluation of Sentinel Lymph Nodes in Breast Cancer
NCT ID:
NCT01140763
Condition:
Breast Neoplasms
Breast Diseases
Conditions: Official terms:
Breast Neoplasms
Breast Diseases
Conditions: Keywords:
metastasis
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Sysmex's 5-blade lymph node cutter
Description:
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.
Arm group label:
Sysmex's 5-blade cutter.
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.
Criteria for eligibility:
Study pop:
Patients with a previous diagnosis of breast cancer scheduled for sentinel lymph node
dissection.
Sampling method:
Probability Sample
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Breast Care Specialist, PC
Address:
City:
Allentown
Zip:
18104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Charlotte Bryk
Phone:
610-366-7333
Email:
cbryk2@yahoo.com
Investigator:
Last name:
Mark A Gittleman, MD
Email:
Principal Investigator
Start date:
August 2010
Completion date:
March 2012
Lead sponsor:
Agency:
Sysmex America, Inc.
Agency class:
Industry
Source:
Sysmex America, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01140763
