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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23DE020197-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
| Indiana University | OTHER |
| M.D. Anderson Cancer Center | OTHER |
| Memorial Sloan Kettering Cancer Center |
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This study seeks to identify risk factors associated with the development of a jaw condition seen in patients with cancer treated with certain medications.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONJ | Patient with cancer involving the bone treated with osteoclast inhibitor (bisphosphonate) and has developed ONJ | ||
| No ONJ | Patient with cancer involving the bone treated with osteoclast inhibitor (bisphosphonate) and has NOT developed ONJ |
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| Measure | Description | Time Frame |
|---|---|---|
| To identify clinical and epidemiologic characteristics associated with ONJ in patients with metastatic bone disease treated with a nitrogen containing bisphosphonate. | analysis is ongoing | 2009-2014 |
| 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. | analysis is ongoing | 2009-2014 |
| To generate a multifactorial index of ONJ risk by multivariate analysis of the clinical, epidemiologic and genetic factors | analysis is ongoing | 2009-2014 |
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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:
Medical records available for data abstraction
Exclusion Criteria:
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Academic medical center(s)
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Van Poznak, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009362 | Neoplasm Metastasis |
| D010020 | Osteonecrosis |
| D059266 | Bisphosphonate-Associated Osteonecrosis of the Jaw |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
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| OTHER |
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paraffin embedded tissue block and/or WBC
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |