NCT02218554|Unknown
Performance Evaluation of the Micromedic BRONJ Risk Assessment in Vitro Diagnostic Assay
BRONJ
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BRONJ
Sponsor study identifier
interventional
150
1 country
2
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
August 13, 2014
Actual (reported)August 18, 2014
Actual (reported)December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
Safety endpoints will include adverse events (AEs), including serious AEs (SAEs) whether or not deemed related to study procedures
2 years
Subject has been diagnosed with BRONJ
Subject has not developed any signs or symptoms of BRONJ
collection of the blood sample from the subject for evaluation of the Micromedic BRONJ Risk Assessment in vitro Diagnostic Assay
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sheba Medical Center
Tel Litwinsky, Israel
Sheba Medical Center
Tel Litwinsky, Israel
Noam Yarom, Dr.
Sheba MC
First Submitted
August 13, 2014
First Posted
August 18, 2014
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Estimated (date passed)Medical and Surgical Treatment of MRONJ (Medication-related Osteonecrosis of the Jaw Bones)
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 18, 2014
Record last verified: 2014-05
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Source: ClinicalTrials.gov.
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