|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01136369 |
|
Date of registration:
|
01/06/2010 |
|
Primary sponsor: |
|
|
Public title:
|
Clinical Evaluation of OSNA Breast Cancer System to Test Sentinel Lymph Nodes From Patients With Breast Cancer
|
|
Scientific title:
|
Clinical Evaluation of LS-03M/LS-04R for the Detection of Sentinel Lymph Node Metastasis From Breast Cancer |
|
Date of first enrolment:
|
February 2007 |
|
Target sample size:
|
496 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01136369 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Case-Only, Time Perspective: Prospective
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Male or Female patients, over the age of 18, diagnosed pre-surgically with T1 or T2
breast cancer and scheduled for surgery including sentinel node dissection.
- Patients who have read and understand the informed consent form and are capable and
willing to provide written informed consent.
Exclusion Criteria:
- Patients diagnosed pre-surgically with large or locally advanced (T3 and T4) breast
cancers.
- Patients diagnosed with inflammatory breast cancer.
- Patients diagnosed with ductal carcinoma in situ (DCIS) when breast conserving is to
be done.
- Patients who are pregnant, as confirmed by a patient/treating physician interview.
- Patients with suspicious palpable axillary lymph nodes.
- Patients currently being treated for or previously diagnosed with, another type of
carcinoma.
- Patients who have undergone prior non-oncologic breast surgery or axillary surgery.
- Patients who have received pre-operative systemic therapy.
- Patients who are incapable of providing written informed consent.
- Patients who have been judged to be inappropriate by a medical care provider (i.e.
surgeon, oncologist, pathologists, etc.).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Breast Diseases
|
|
Breast Neoplasms
|
|
Intervention(s)
|
|
Device: OSNA Breast Cancer System
|
|
Primary Outcome(s)
|
|
The study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the OSNA Breast Cancer System by comparing its performance to permanent section staining.
[Time Frame: 2 years]
|
|
The time required to perform the trial method will be measured and evaluated for intra-operative use.
[Time Frame: 2 Years]
|
|
Secondary ID(s)
|
|
OSNA-BC-001
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|