Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer
Panoramica dello studio
Stato
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109
- University of Michigan
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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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.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 2009-2014
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analysis is ongoing
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2009-2014
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Catherine Van Poznak, MD, University of Michigan
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Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HUM00040101
- 5K23DE020197-02 (Sovvenzione/contratto NIH degli Stati Uniti)
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