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

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

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).

Study Overview

• Status: Unknown
• Conditions: Bisphosphonate-related Osteonecrosis of the Jaw
• Intervention / Treatment: Genetic: BRONJ

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noam Yarom, Dr.; Phone Number: 972-35303819; Email: noamyar@post.tau.ac.il

Study Locations

• Israel
  • Tel Hashomer, Israel
    • Recruiting
    • Sheba Medical Center
    • Contact: Noam Yarom, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Time Frame
Safety endpoints will include adverse events (AEs), including serious AEs (SAEs) whether or not deemed related to study procedures	2 years

Collaborators and Investigators

• Sponsor: Micromedic Technologies Ltd
• Investigators: Principal Investigator: Noam Yarom, Dr., Sheba MC

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: August 13, 2014
• First Submitted That Met QC Criteria: August 14, 2014
• First Posted (Estimate): August 18, 2014

Study Record Updates

• Last Update Posted (Estimate): August 18, 2014
• Last Update Submitted That Met QC Criteria: August 14, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: BRONJ
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Musculoskeletal Diseases; Stomatognathic Diseases; Bone Diseases; Jaw Diseases; Osteonecrosis; Bisphosphonate-Associated Osteonecrosis of the Jaw
• Other Study ID Numbers: CL-BNJ-001-PR