Breast CancerNCT00551278
Validation Study Using the GeneSearch BLN Assay to Test Sentinel Lymph Nodes From Patients With Breast Cancer
An observational study of Breast Cancer, run by Janssen Diagnostics, LLC at 1 site in United States.
Trial summary
The purpose of this trial is to show adequate assay performance on clinical samples tested in real time at the clinical site. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- GeneSearch™ Breast Lymph Node (BLN) Assay
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Dec 2009
- 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
- Previous diagnosis of carcinoma of the breast
- Patient scheduled for sentinel lymph node dissection as per standard of care at the clinical site
- 18 years or older
- Female or male, and
- Able and willing to give consent to participate in the study
Who cannot join
- Patients taking part in other research studies that would interfere with their full participation in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: GeneSearch™ Breast Lymph Node (BLN) Assay for Molecular Testing Protocol
The purpose of this trial is to show adequate assay performance on clinical samples tested in real time at the clinical site.
Read the detailed description
This study will determine the sensitivity, specificity, negative predictive value, and positive predictive value of the GeneSearch™ BLN Assay in patient samples by comparing its performance to that of the current methods -- permanent section Hematoxylin and Eosin (H\&E) staining with IHC. Additional marker testing using probes associated with nodal metastases may be used in the assay performance calculations. The observed performance measures will be compared to those obtained in the larger U.S. registration trial to show that there are no differences in the assay's performance.
- Conditions
- Breast Cancer
- Being tested
- GeneSearch™ Breast Lymph Node (BLN) Assay
- Keywords
- sentinel lymph node, metastasis, molecular pathology
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GeneSearch™ Breast Lymph Node (BLN) AssayDevice
For in vitro diagnostic use only.
The GeneSearch™ Breast Lymph Node (BLN) Assay is a qualitative, 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.
Post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using the Veridex lymph node cutting scheme, is required.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with previous diagnosis of breast cancer scheduled for sentinel lymph node dissection. Receives: Device: GeneSearch™ Breast Lymph Node (BLN) Assay |
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 GeneSearch™ BLN Assay by comparing its performance to permanent section Hematoxylin and Eosin (H&E) staining with IHC.
Measured: 1 month
Secondary outcomes (1)
A secondary objective will assess the timing and logistical aspects of introducing a real time molecular test within the pathology lab.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Diagnostics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert J. Goulet, MD, Principal investigator, Indiana University Cancer Pavilion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551278
- Sponsor's protocol ID
- BLN-US-IU-2006.00
- Status last verified
- Jan 2016
- First submitted
- 26 Oct 2007
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GeneSearch™ Breast Lymph Node (BLN) Assay for Molecular Testing Protocol
- ClinicalTrials.gov ID
- NCT00551278
- Acronym / sponsor ID
- BLN-US-IU-2006.00
- Conditions
- Breast Cancer
- Keywords
- sentinel lymph node, metastasis, molecular pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Janssen Diagnostics, LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 30 Oct 2007 (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 purpose of this trial is to show adequate assay performance on clinical samples tested in real time at the clinical site.
Detailed description
This study will determine the sensitivity, specificity, negative predictive value, and positive predictive value of the GeneSearch™ BLN Assay in patient samples by comparing its performance to that of the current methods -- permanent section Hematoxylin and Eosin (H\&E) staining with IHC. Additional marker testing using probes associated with nodal metastases may be used in the assay performance calculations. The observed performance measures will be compared to those obtained in the larger U.S. registration trial to show that there are no differences in the assay's performance.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: GeneSearch™ Breast Lymph Node (BLN) AssayPatients with previous diagnosis of breast cancer scheduled for sentinel lymph node dissection. |
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 (5 listed)
- Previous diagnosis of carcinoma of the breast
- Patient scheduled for sentinel lymph node dissection as per standard of care at the clinical site
- 18 years or older
- Female or male, and
- Able and willing to give consent to participate in the study
Key exclusion criteria (1 listed)
- Patients taking part in other research studies that would interfere with their full participation in this study
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 |
|---|---|---|
| GeneSearch™ Breast Lymph Node (BLN) AssayFor in vitro diagnostic use only. The GeneSearch™ Breast Lymph Node (BLN) Assay is a qualitative, 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. Post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using the Veridex lymph node cutting scheme, is required. | Device | 1 |
Primary outcome
The study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the GeneSearch™ BLN Assay by comparing its performance to permanent section Hematoxylin and Eosin (H&E) staining with IHC.
Time frame: 1 month
1 secondary outcome
A secondary objective will assess the timing and logistical aspects of introducing a real time molecular test within the pathology lab.
Time frame: 1 day
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 12 Jan 2016.
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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.
Robert J. Goulet, MD principal investigator
Indiana University Cancer Pavilion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Janssen Diagnostics, LLC at 1 site 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 5 inclusion and 1 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 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 GeneSearch™ BLN Assay by comparing its performance to permanent section Hematoxylin and Eosin (H&E) staining with IHC. (time frame: 1 month). 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 12 Jan 2016.