To evaluate the performance of the Micromedic BRONJ Risk Assessment in vitro assay (the "BRONJ Assay") in identifying Multiple Myeloma (MM) and/or other cancer subjects at risk for developing Bisphosphonate-related Osteonecrosis of the Jaw (BRONJ) following intravenous (IV) administration of Bisphosphonates (BP).
The Micromedic BRONJ Assay is intended for the qualitative analysis of genetic changes which may be indicative of increased risk to develop BRONJ osteonecrosis of the jaw (ONJ) following IV administration of drugs of the Bisphosphonate family.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
150
collection of the blood sample from the subject for evaluation of the Micromedic BRONJ Risk Assessment in vitro Diagnostic Assay
Sheba Medical Center
Tel Litwinsky, Israel
RECRUITINGSheba Medical Center
Tel Litwinsky, Israel
RECRUITINGFor each subject, the primary endpoint is the presence or absence of SNPs or other genetic alterations obtained from the assay for blood samples
Time frame: up to 2 years
For each subject, the secondary endpoint is the presence or absence of additional/alternative SNPs or other genetic alterations using GWAS analysis and/or Full Exome Sequencing (FES) from the assay for blood samples
Time frame: up to 2 years
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