Clinical Evaluation of Tissue Sampling Bias in Histologic Evaluation of Sentinel Lymph Nodes in Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | August 2010 |
| End Date: | March 2012 |
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.
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.
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).
We found this trial at
1
site
Click here to add this to my saved trials
