Clinical trial NCT01325142: Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer
Official title: Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Diseases
Metastases
Osteonecrosis
Bisphosphonate-Associated Osteonecrosis of the Jaw
Keywords: Osteonecrosis of the Jaw (ONJ)
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
name: Indiana University
name: M.D. Anderson Cancer Center
name: Memorial Sloan Kettering Cancer Center
First posted: 2011-03-29
Enrollment: 271
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Academic medical center(s)

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

Eligibility criteria: 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

Primary outcomes:
measure: To identify clinical and epidemiologic characteristics associated with ONJ in patients with metastatic bone disease treated with a nitrogen containing bisphosphonate.
timeFrame: 2009-2014
measure: 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.
timeFrame: 2009-2014
measure: To generate a multifactorial index of ONJ risk by multivariate analysis of the clinical, epidemiologic and genetic factors
timeFrame: 2009-2014
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Catherine Van Poznak, MD
role: PRINCIPAL_INVESTIGATOR
References: