Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer
研究概览
地位
条件
详细说明
The goal of this research is to build an index of risk for estimating an individual's risk of developing osteonecrosis of the jaw (ONJ). The bisphosphonates are an important supportive therapy in the care of patients with metastatic bone disease; they are able to prevent catastrophic events such as fracture and spinal cord compression. However, ONJ has been associated with the use of the bisphosphonates and ONJ carries significant morbidity. Presently, there are insufficient data to calculate the ONJ risk benefit ratio of bisphosphonate use. An ONJ risk assessment tool would improve both the oncologist's and the dental health professional the ability to anticipate and potentially mitigate oral toxicities from bisphosphonate therapy.
This protocol consists of a case (ONJ) control (no ONJ) study to identify factors associated with the risk of ONJ and to build an index predictive of an individual's risk of developing ONJ. The index of ONJ risk will be comprised of clinical, epidemiologic and genetic factors
研究类型
注册 (实际的)
联系人和位置
学习地点
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Michigan
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Ann Arbor、Michigan、美国、48109
- University of Michigan
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- The study candidate must have sufficient Formalin Fixed Paraffin Embedded (FFPE)Specimens (lymph node or tumor) for DNA extraction available for study SNP assessment
- Patients over the age of 21 with a histologically confirmed diagnosis of cancer who have received nitrogen containing bisphosphonate therapy for metastatic bone disease.
- FFPE tissues are to have been removed for clinical indication and sufficience study volume of specimen must be available in an established tissue repository.
- Study FFPE tissues include:
- formalin fixed paraffin embedded leukocytes from lymph nodes with or without involvement by tumor AND/OR
- formalin fixed paraffin embedded tumor tissue (tumor block without invasive cancer is acceptable if the specimen is believed to be sufficiently cellular (breast tissue or noninvasive cancer) to yield adequate DNA)
- Medical records available for data abstraction
Exclusion Criteria:
- Insufficient specimen available to perform the assays proposed for specimen DNA analysis
- No accessable medical records
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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ONJ
Patient with cancer involving the bone treated with osteoclast inhibitor (bisphosphonate) and has developed ONJ
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No ONJ
Patient with cancer involving the bone treated with osteoclast inhibitor (bisphosphonate) and has NOT developed ONJ
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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To identify clinical and epidemiologic characteristics associated with ONJ in patients with metastatic bone disease treated with a nitrogen containing bisphosphonate.
大体时间：2009-2014
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analysis is ongoing
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2009-2014
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To identify single nucleotide polymorphisms (SNPs) in genes affected by osteoclast inhibiting therapy that are associated with an increased risk of developing ONJ in patients with metastatic bone disease treated with nitrogen containing bisphosphonates.
大体时间：2009-2014
|
analysis is ongoing
|
2009-2014
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To generate a multifactorial index of ONJ risk by multivariate analysis of the clinical, epidemiologic and genetic factors
大体时间：2009-2014
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analysis is ongoing
|
2009-2014
|
合作者和调查者
合作者
调查人员
- 首席研究员：Catherine Van Poznak, MD、University of Michigan
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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