Breast NeoplasmsNCT01136369
Clinical Evaluation of OSNA Breast Cancer System to Test Sentinel Lymph Nodes From Patients With Breast Cancer
An observational study of Breast Neoplasms and Breast Diseases, run by Sysmex America, Inc. at 11 sites in United States.
Trial summary
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 Hematoxylin and Eosin (H\&E) and IHC staining. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, Breast Diseases
- What is being tested?
- OSNA Breast Cancer System
- Type of treatment
- Medical device
- How many people
- 496 participants
- Where
- 11 sitesUnited States
- Study dates
- Feb 2007to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a previous diagnosis of breast cancer scheduled for sentinel lymph node dissection.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.).
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Breast Care Specialist, PC
Allentown, Pennsylvania, 18104
Dallas Surgical Group
Dallas, Texas, 75230
Central Carolina Surgery, PA
Greensboro, North Carolina, 27401
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
WellStar Health Systems
Marietta, Georgia, 30062
Nashville Breast Center, PC
Nashville, Tennessee, 37203
Beth Israel Medical Center
New York, New York, 10003
John Wayne Cancer Institute
Santa Monica, California, 90404
Washington University Medical School
St Louis, Missouri, 63110
Breast Care Specialist, Inc.
Westerville, Ohio, 43081
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Clinical Evaluation of LS-03M/LS-04R for the Detection of Sentinel Lymph Node Metastasis From Breast Cancer
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 Hematoxylin and Eosin (H\&E) and IHC staining.
- Conditions
- Breast Neoplasms, Breast Diseases
- Being tested
- OSNA Breast Cancer System
- Keywords
- metastasis, molecular pathology
- Medical subject headings
- Breast Neoplasms, Breast Diseases, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSNA Breast Cancer SystemDevice
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 (> 0.2 mm). An assay positive ++ result predicts the presence of macrometastasis (> 2 mm).
Post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using the Sysmex lymph node cutting scheme, is required.
| Study group | Role | What they receive |
|---|---|---|
| OSNA Breast Cancer System | Not described Receives: Device: OSNA Breast Cancer System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
The time required to perform the trial method will be measured and evaluated for intra-operative use.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startFeb 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 496 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sysmex America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136369
- Sponsor's protocol ID
- OSNA-BC-001
- Status last verified
- Jun 2010
- First submitted
- 1 Jun 2010
- Last updated
- 3 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of LS-03M/LS-04R for the Detection of Sentinel Lymph Node Metastasis From Breast Cancer
- ClinicalTrials.gov ID
- NCT01136369
- Acronym / sponsor ID
- OSNA-BC-001
- Conditions
- Breast Neoplasms, Breast Diseases
- Keywords
- metastasis, molecular pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 496 participants (actual)
- Lead sponsor
- Sysmex America, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 3 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Hematoxylin and Eosin (H\&E) and IHC staining.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSNA Breast Cancer System | – | Device: OSNA Breast Cancer System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a previous diagnosis of breast cancer scheduled for sentinel lymph node dissection.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OSNA Breast Cancer SystemFor 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 (> 0.2 mm). An assay positive ++ result predicts the presence of macrometastasis (> 2 mm). Post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using the Sysmex lymph node cutting scheme, is required. | Device | OSNA Breast Cancer System |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2010.
Related trials for Breast Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Breast Diseases, run by Sysmex America, Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2010.