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

Bisphosphonate-related Osteonecrosis of the Jaw Clinical Trial

— BRONJ  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02218554
• Other study ID #: CL-BNJ-001-PR
• Status: Recruiting
• Phase: N/A
• First received: August 13, 2014
• Last updated: August 14, 2014
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: May 2014
• Source: Micromedic Technologies Ltd
• Contact: Noam Yarom, Dr.
• Phone: 972-35303819
• Email: noamyar[@]post.tau.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bisphosphonate-Associated Osteonecrosis of the Jaw
• Bisphosphonate-related Osteonecrosis of the Jaw
• Osteonecrosis

Intervention

Genetic:
• BRONJ
collection of the blood sample from the subject for evaluation of the Micromedic BRONJ Risk Assessment in vitro Diagnostic Assay

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel Hashomer
Israel	Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Micromedic Technologies Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety endpoints will include adverse events (AEs), including serious AEs (SAEs) whether or not deemed related to study procedures		2 years	Yes
Primary	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	No
Secondary	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	No