Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer
調査の概要
状態
詳細な説明
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
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- University of Michigan
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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.
時間枠：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.
時間枠：2009-2014
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analysis is ongoing
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2009-2014
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To generate a multifactorial index of ONJ risk by multivariate analysis of the clinical, epidemiologic and genetic factors
時間枠：2009-2014
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analysis is ongoing
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2009-2014
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Catherine Van Poznak, MD、University of Michigan
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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