Clinical Evaluation of Tissue Sampling Bias in Histologic Evaluation of Sentinel Lymph Nodes in Breast Cancer
Status unconfirmed
Conditions studied: Breast Neoplasms, Breast Diseases
In brief
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.
Key facts
- Study ID
- NCT01140763
- Run by
- Sysmex America, Inc.
- People needed
- 75
- Starts
- 2010-08-01
- Expected to finish
- 2012-03-01
- Last updated by the study team
- 2010-08-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
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).
Where it is running
- Breast Care Specialist, PC — Allentown, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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