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

Not Applicable

• Conditions: Bisphosphonate-related Osteonecrosis of the Jaw
• Interventions: Genetic: BRONJ

• Registration Number: NCT02218554
• Lead Sponsor: Micromedic Technologies Ltd

Brief Summary

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

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 Timeline

• Study Start: 2012-01
• Status Verified: 2014-05
• Study First Submitted: 2014-08-13
• Study First Submitted QC: 2014-08-14
• Last Update Submitted: 2014-08-14
• Study First Posted: 2014-08-18
• Last Update Posted: 2014-08-18
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Inclusion Criteria Study Group (all of the following):

1. Subject is ≥18 years old
2. 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
3. Subject has been diagnosed with BRONJ at stages 1 or 2 or 3 according to AAOMS (American Association of Oral and Maxillofacial Surgeons)
4. Subject has signed the informed consent or consent can be waived

Inclusion Criteria Control Group (all of the following):

1. Subject is ≥18 years old
2. 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)
3. Subject has not developed any signs or symptoms of BRONJ
4. Subject has signed the informed consent or consent can be waived

Exclusion Criteria

1. Subject has been treated with irradiation to the jaws or head and neck at levels exceeding 35 Gy
2. Pregnant or lactating women
3. Subject has been treated with either bevacizumab or sunitimib
4. Subject has been treated with Allogeneic hematopoietic stem cell transplantation (HSCT)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	BRONJ	Subject has been diagnosed with BRONJ

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel