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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02218554 |
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Date of registration:
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13/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Performance Evaluation of the Micromedic BRONJ Risk Assessment in Vitro Diagnostic Assay
BRONJ |
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Scientific title:
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Performance Evaluation of the Micromedic BRONJ Risk Assessment in Vitro Diagnostic Assay. |
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Date of first enrolment:
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January 2012 |
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Target sample size:
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150 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02218554 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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Israel
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Contacts
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Name:
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Noam Yarom, Dr. |
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Address:
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Telephone:
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972-35303819 |
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Email:
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noamyar@post.tau.ac.il |
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Affiliation:
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Name:
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Noam Yarom, Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sheba MC |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bisphosphonate-related Osteonecrosis of the Jaw
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Intervention(s)
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Genetic: BRONJ
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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CL-BNJ-001-PR
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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