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


N/A
21 Years
N/A
Open (Enrolling by invite only)
Both
Bone and Bones, Metastases, Osteonecrosis, Diphosphonates

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Trial Information

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


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
bisphoshonate 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


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Retrospective

Principal Investigator

Catherine Van Poznak, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan

Authority:

United States: Institutional Review Board

Study ID:

HUM00040101

NCT ID:

NCT01325142

Start Date:

August 2010

Completion Date:

Related Keywords:

  • Bone and Bones
  • Metastases
  • Osteonecrosis
  • Diphosphonates
  • Osteonecrosis of the Jaw (ONJ)
  • Neoplasm Metastasis
  • Osteonecrosis

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624