Expired Study
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Tucson, Arizona 85724


Purpose:

The study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the OSNA Breast Cancer System for patients receiving Sentinel Lymph Node biopsies after receiving neoadjuvant hormonal/chemotherapy as compared to permanent section Hematoxylin and Eosin (H&E) and Immuno-histochemistry (IHC) staining.


Criteria:

Inclusion Criteria: - Male or female - 18 years of age or older - Diagnosed pre‐surgically with T1‐T3 or T4 non‐inflammatory breast cancer, clinically node positive or node negative upon clinical examination - Scheduled for SLN biopsy after receiving neoadjuvant hormonal or chemotherapy - Subjects (or the subjects' legal representatives) who have read, understood (to the best of their ability) and signed the informed consent form. Exclusion Criteria: - Pregnant subjects, confirmed by interview with either subject or treating physician - Subjects previously diagnosed with other invasive cancer. Subjects with skin cancer (basal cell and squamous cell carcinoma) may be included, except for subjects diagnosed with melanoma - Participation in other neoadjuvant protocols specifically requiring SLN biopsy prior to administration of neoadjuvant chemotherapy or hormonal therapy - Subjects who have been judged to be an inappropriate candidate by any medical care provider (e.g., surgeon, oncologist or pathologist).


Study is Available At:


Original ID:

OSNA-BC-NEO-001


NCT ID:

NCT01140776


Secondary ID:


Study Acronym:


Brief Title:

Clinical Evaluation of OSNA Breast Cancer System in Breast Cancer Patients Receiving Neoadjuvant Therapy


Official Title:

OSNA Neoadjuvant Feasibility Study in Breast Cancer Patients


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Sysmex America, Inc.


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case-Only, Time Perspective:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

100


Enrollment Type:

Anticipated


Study Dates

Start Date:November 2010
Completion Date:July 2012
Completion Type:Anticipated
Primary Completion Date:July 2012
Primary Completion Type:Anticipated
Verification Date:June 2011
Last Changed Date:June 6, 2011
First Received Date:June 3, 2010

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Determine incidence of breast cancer recurrence in axillary lymph nodes and distant organs within 5 years in study subjects (Phase II).
Time Frame:18 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Correlate OSNA results and histology results with the status of non‐sentinel lymph nodes.
Time Frame:18 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Compare performance of the OSNA Breast Cancer System to intraoperative frozen section methods (mandatory) and imprint cytology methods (optional) with standard histopathology results from permanent sections.
Time Frame:18 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Prospectively assess the performance of the OSNA Breast Cancer System for the detection of SLN metastasis in subjects treated with neoadjuvant therapy prior to SLN biopsy by comparing results with standard histopathology evaluation.
Time Frame:18 months
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:OSNA Breast Cancer System
Description:For in vitro diagnostic use only. The OSNA Breast Cancer System is an automated semi-quantitative, in vitro diagnostic test for the rapid detection of greater than (>) 0.2 mm metastases in nodal tissue removed from sentinel lymph node biopsies of breast cancer patients. Results from the assay can be used to guide the intra-operative or post-operative decision to remove additional lymph nodes and to aid in patient staging. An assay positive + or ++ result indicates the presence of metastasis

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Sysmex America, Inc.

Samples and Retentions

Sample Retention:Samples With DNA
Description: Samples of the tissue homogenate will be retained and may be used for for further testing.
Study Population: Patients with a previous diagnosis of breast cancer scheduled for sentinel lymph node dissection after receiving neoadjuvant hormonal/chemotherapy.
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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