Performance Evaluation of the Micromedic BRONJ Risk Assessment in Vitro Diagnostic Assay

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Performance Evaluation of the Micromedic BRONJ Risk Assessment in Vitro Diagnostic Assay.

Conditions
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Bisphosphonate-related Osteonecrosis of the Jaw

Intervention / Treatment
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* Genetic: BRONJ


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria Study Group (all of the following): Subject is ≥18 years old Subject is or was a Multiple Myeloma and/or other cancer patient who is or has been IV treated with the BP zoledronic acid and/or pamidronate disodium; Or; Subject is or was a Multiple Myeloma and/or other cancer patient who is or has been IV treated with the BP zoledronic acid and/or pamidronate disodium and was also treated by oral BP such as sodium alendronate, and in the opinion of the PI, IV treatment was significant enough to be considered as the cause for BRONJ Subject has been diagnosed with BRONJ at stages 1 or 2 or 3 according to AAOMS (American Association of Oral and Maxillofacial Surgeons) Subject has signed the informed consent or consent can be waived Inclusion Criteria Control Group (all of the following): Subject is ≥18 years old Subject is or was a Multiple Myeloma and/or other cancer patient who is, or has been IV treated with the BP zoledronic acid and/or pamidronate disodium for at least two (2) years (continuously or cumulatively) Subject has not developed any signs or symptoms of BRONJ Subject has signed the informed consent or consent can be waived Exclusion Criteria: Subject has been treated with irradiation to the jaws or head and neck at levels exceeding 35 Gy Pregnant or lactating women Subject has been treated with either bevacizumab or sunitimib Subject has been treated with Allogeneic hematopoietic stem cell transplantation (HSCT)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Subject has been diagnosed with BRONJ | Genetic: BRONJ<br>* collection of the blood sample from the subject for evaluation of the Micromedic BRONJ Risk Assessment in vitro Diagnostic Assay<br>|
| No Intervention: Control Group<br>Subject has not developed any signs or symptoms of BRONJ | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BRONJ