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

Primary Purpose

Bisphosphonate-related Osteonecrosis of the Jaw

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
BRONJ
Sponsored by
Micromedic Technologies Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bisphosphonate-related Osteonecrosis of the Jaw focused on measuring BRONJ

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Sheba Medical CenterRecruiting
  • Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study Group

Control Group

Arm Description

Subject has been diagnosed with BRONJ

Subject has not developed any signs or symptoms of BRONJ

Outcomes

Primary Outcome Measures

For each subject, the primary endpoint is the presence or absence of SNPs or other genetic alterations obtained from the assay for blood samples

Secondary Outcome Measures

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

Full Information

First Posted
August 13, 2014
Last Updated
August 14, 2014
Sponsor
Micromedic Technologies Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02218554
Brief Title
Performance Evaluation of the Micromedic BRONJ Risk Assessment in Vitro Diagnostic Assay
Acronym
BRONJ
Official Title
Performance Evaluation of the Micromedic BRONJ Risk Assessment in Vitro Diagnostic Assay.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Micromedic Technologies Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bisphosphonate-related Osteonecrosis of the Jaw
Keywords
BRONJ

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
Subject has been diagnosed with BRONJ
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Subject has not developed any signs or symptoms of BRONJ
Intervention Type
Genetic
Intervention Name(s)
BRONJ
Intervention Description
collection of the blood sample from the subject for evaluation of the Micromedic BRONJ Risk Assessment in vitro Diagnostic Assay
Primary Outcome Measure Information:
Title
For each subject, the primary endpoint is the presence or absence of SNPs or other genetic alterations obtained from the assay for blood samples
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
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
Time Frame
up to 2 years
Other Pre-specified Outcome Measures:
Title
Safety endpoints will include adverse events (AEs), including serious AEs (SAEs) whether or not deemed related to study procedures
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noam Yarom, Dr.
Phone
972-35303819
Email
noamyar@post.tau.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noam Yarom, Dr.
Organizational Affiliation
Sheba MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Tel Hashomer
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noam Yarom, Dr.
First Name & Middle Initial & Last Name & Degree
Noam Yarom, Dr
Facility Name
Sheba Medical Center
City
Tel Hashomer
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noam Yarom, Dr

12. IPD Sharing Statement

Learn more about this trial

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

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