Clinical trial · Observational
GeneSearch™ Breast Lymph Node (BLN) Assay Post Approval Study
NCT00595296CI-TRIAL-00020493terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): GeneSearch™ BLN Assay has been voluntarily withdrawn from the US market.
Summary
Brief summary (as posted)
This post-approval study is designed to determine the performance of the FDA-approved GeneSearch™ BLN Assay when compared to the site's standard of care permanent section histological evaluation, and when compared to more extensive histological evaluation when the assay is being used by clinicians to make surgical decisions on complete axillary dissections (ALND).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GeneSearch™ Breast Lymph Node (BLN) Assay | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- All eligible patients.
- interventionNames
- Device: GeneSearch™ Breast Lymph Node (BLN) Assay
Primary outcomes (1)
- measure
- To estimate the positive predictive concordance (PPC) between the GeneSearch™ BLN Assay and histology as routinely practiced.
- timeFrame
- 1 week
Secondary outcomes (2)
- measure
- To estimate the positive predictive value (PPV) of the GeneSearch™ BLN Assay as measured against histology that is as accurate as possible in assessing whether a SLN is truly positive.
- timeFrame
- 1 week
- measure
- To gather data on size of metastases (micrometastases versus macrometastases) identified by histology to examine the assay performance for various levels of metastases.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pre-operatively established diagnosis of invasive carcinoma of the breast * Scheduled for axillary sentinel lymph node dissection as per standard of care at the clinical site for newly diagnosed breast cancer patients * Patients for whom the GeneSearch™ BLN Assay will be used intra-operatively to make a decision for an axillary lymph node dissection * 18 years of age or older * Female or male * Willing and able to give informed consent to participate in the study Exclusion Criteria: * Previous diagnosis of lymphoma * Subjects participating in other research studies that would interfere with their full participation in this study * Patients and/or conditions with 'interfering substances' as listed in the IFU. * Patients who have had any pre-operative treatment for breast cancer including neoadjuvant and/or hormonal intervention such as aromatase inhibitors or tamoxifen
References
Publications (3)
- BACKGROUNDBlumencranz P, Whitworth PW, Deck K, Rosenberg A, Reintgen D, Beitsch P, Chagpar A, Julian T, Saha S, Mamounas E, Giuliano A, Simmons R. Scientific Impact Recognition Award. Sentinel node staging for breast cancer: intraoperative molecular pathology overcomes conventional histologic sampling errors. Am J Surg. 2007 Oct;194(4):426-32. doi: 10.1016/j.amjsurg.2007.07.008. PMID 17826050
- BACKGROUNDJulian TB, Blumencranz P, Deck K, Whitworth P, Berry DA, Berry SM, Rosenberg A, Chagpar AB, Reintgen D, Beitsch P, Simmons R, Saha S, Mamounas EP, Giuliano A. Novel intraoperative molecular test for sentinel lymph node metastases in patients with early-stage breast cancer. J Clin Oncol. 2008 Jul 10;26(20):3338-45. doi: 10.1200/JCO.2007.14.0665. PMID 18612150
- BACKGROUNDVeys I, Majjaj S, Salgado R, Noterman D, Schobbens JC, Manouach F, Bourgeois P, Nogaret JM, Larsimont D, Durbecq V. Evaluation of the histological size of the sentinel lymph node metastases using RT-PCR assay: a rapid tool to estimate the risk of non-sentinel lymph node invasion in patients with breast cancer. Breast Cancer Res Treat. 2010 Dec;124(3):599-605. doi: 10.1007/s10549-009-0555-2. Epub 2009 Sep 25. PMID 19779817