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

Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325142
• Other study ID #: HUM00040101
• Secondary ID: 5K23DE020197-02
• Status: Completed
• Phase: N/A
• First received: March 28, 2011
• Last updated: December 1, 2014
• Start date: August 2010
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Bisphosphonate-Associated Osteonecrosis of the Jaw
• Bone Diseases
• Metastases
• Neoplasm Metastasis
• Osteonecrosis

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (5)

Lead Sponsor	Collaborator
University of Michigan	Indiana University, M.D. Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	To generate a multifactorial index of ONJ risk by multivariate analysis of the clinical, epidemiologic and genetic factors	analysis is ongoing	2009-2014	No