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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02218554
Recruitment Status : Unknown
Verified May 2014 by Micromedic Technologies Ltd.
Recruitment status was:  Recruiting
First Posted : August 18, 2014
Last Update Posted : August 18, 2014
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Bisphosphonate-related Osteonecrosis of the Jaw Genetic: BRONJ Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Performance Evaluation of the Micromedic BRONJ Risk Assessment in Vitro Diagnostic Assay.
Study Start Date : January 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteonecrosis

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



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 Outcome Measures:
  1. Safety endpoints will include adverse events (AEs), including serious AEs (SAEs) whether or not deemed related to study procedures [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218554


Contacts
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Contact: Noam Yarom, Dr. 972-35303819 noamyar@post.tau.ac.il

Locations
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Israel
Sheba Medical Center Recruiting
Tel Hashomer, Israel
Contact: Noam Yarom, Dr.         
Principal Investigator: Noam Yarom, Dr         
Sheba Medical Center Recruiting
Tel Hashomer, Israel
Contact: Noam Yarom, Dr         
Sponsors and Collaborators
Micromedic Technologies Ltd
Investigators
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Principal Investigator: Noam Yarom, Dr. Sheba MC

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Responsible Party: Micromedic Technologies Ltd
ClinicalTrials.gov Identifier: NCT02218554     History of Changes
Other Study ID Numbers: CL-BNJ-001-PR
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: August 18, 2014
Last Verified: May 2014

Keywords provided by Micromedic Technologies Ltd:
BRONJ

Additional relevant MeSH terms:
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Osteonecrosis
Bisphosphonate-Associated Osteonecrosis of the Jaw
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes
Jaw Diseases
Stomatognathic Diseases