NCT02218554Unknown不适用
Performance Evaluation of the Micromedic BRONJ Risk Assessment in Vitro Diagnostic Assay.
Micromedic Technologies Ltd1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2012年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- For each subject, the primary endpoint is the presence or absence of SNPs or other genetic alterations obtained from the assay for blood samples
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
For each subject, the primary endpoint is the presence or absence of SNPs or other genetic alterations obtained from the assay for blood samples
时间窗: up to 2 years
次要结局
- 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)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
BRight DCB First-in-Human StudyPeripheral Artery DiseaseNCT04525794Biotronik CRC Inc.48
进行中（未招募）
不适用
Clinical Evaluation of the miR Sentinel BCa™ Test to Diagnose Bladder Cancer in Hematuria PatientsBladder CancerNCT04155359miR Scientific LLC444
已完成
不适用
Pilot Study of Biopsy Scanner for Evaluation of Bronchoscopic Small Biopsy Specimens to Determine AdequacyLung CancerNCT05393154Aquyre Bioscience, Inc55
招募中
不适用
Stress Management with Real-time Bio-signal BiofeedbackBipolar Disorder (BD)Major Depressive DiorderNCT06616116Seoul National University Hospital100
已完成
不适用
A Clinical Trial to Evaluate Efficacy and Safety of a Water-soluble Head Lice Product.Head LicePediculosis CapitisNCT03617926Oystershell NV70