Performance Evaluation of the Micromedic BRONJ Risk Assessment in Vitro Diagnostic Assay (NCT02218554) | Clinical Trial Compass
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Performance Evaluation of the Micromedic BRONJ Risk Assessment in Vitro Diagnostic Assay
Israel150 participantsStarted 2012-01
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. 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
What they're measuring
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