Status:
UNKNOWN
Clinical Evaluation of Tissue Sampling Bias in Histologic Evaluation of Sentinel Lymph Nodes in Breast Cancer
Lead Sponsor:
Sysmex America, Inc.
Conditions:
Breast Neoplasms
Breast Diseases
Eligibility:
All Genders
18+ years
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 complete...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2012
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01140763
Start Date
August 1 2010
End Date
March 1 2012
Last Update
August 30 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Breast Care Specialist, PC
Allentown, Pennsylvania, United States, 18104