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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Subject has been diagnosed with BRONJ |
|
| Control Group | No Intervention | Subject has not developed any signs or symptoms of BRONJ |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BRONJ | Genetic | collection of the blood sample from the subject for evaluation of the Micromedic BRONJ Risk Assessment in vitro Diagnostic Assay |
|
| Measure | Description | Time Frame |
|---|---|---|
| For each subject, the primary endpoint is the presence or absence of SNPs or other genetic alterations obtained from the assay for blood samples | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints will include adverse events (AEs), including serious AEs (SAEs) whether or not deemed related to study procedures | 2 years |
Inclusion Criteria:
Inclusion Criteria Study Group (all of the following):
Inclusion Criteria Control Group (all of the following):
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noam Yarom, Dr. | Contact | 972-35303819 | noamyar@post.tau.ac.il |
| Name | Affiliation | Role |
|---|---|---|
| Noam Yarom, Dr. | Sheba MC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Recruiting | Tel Litwinsky | Israel |
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| ID | Term |
|---|---|
| D059266 | Bisphosphonate-Associated Osteonecrosis of the Jaw |
| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D007571 | Jaw Diseases |
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| Sheba Medical Center | Recruiting | Tel Litwinsky | Israel |
|
| D009057 |
| Stomatognathic Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |