Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01325142

Enrollment

271

Registered

2011-03-29

Start date

2010-08-31

Completion date

2014-11-30

Last updated

2014-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bisphosphonate-Associated Osteonecrosis of the Jaw, Bone Diseases, Metastases, Osteonecrosis

Keywords

Osteonecrosis of the Jaw (ONJ)

Brief summary

This study seeks to identify risk factors associated with the development of a jaw condition seen in patients with cancer treated with certain medications.

Detailed description

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
To identify clinical and epidemiologic characteristics associated with ONJ in patients with metastatic bone disease treated with a nitrogen containing bisphosphonate.	2009-2014	analysis is ongoing
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.	2009-2014	analysis is ongoing
To generate a multifactorial index of ONJ risk by multivariate analysis of the clinical, epidemiologic and genetic factors	2009-2014	analysis is ongoing

Countries

United States

Outcome results