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

This study has been completed.
Sponsor:
Collaborators:
Indiana University
M.D. Anderson Cancer Center
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Catherine Van Poznak, University of Michigan
ClinicalTrials.gov Identifier:
NCT01325142
First received: March 28, 2011
Last updated: December 1, 2014
Last verified: December 2014
  Purpose

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


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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • To identify clinical and epidemiologic characteristics associated with ONJ in patients with metastatic bone disease treated with a nitrogen containing bisphosphonate. [ Time Frame: 2009-2014 ] [ Designated as safety issue: No ]
    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. [ Time Frame: 2009-2014 ] [ Designated as safety issue: No ]
    analysis is ongoing

  • To generate a multifactorial index of ONJ risk by multivariate analysis of the clinical, epidemiologic and genetic factors [ Time Frame: 2009-2014 ] [ Designated as safety issue: No ]
    analysis is ongoing


Biospecimen Retention:   Samples With DNA

paraffin embedded tissue block and/or WBC


Enrollment: 271
Study Start Date: August 2010
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
ONJ
Patient with cancer involving the bone treated with osteoclast inhibitor (bisphosphonate) and has developed ONJ
No ONJ
Patient with cancer involving the bone treated with osteoclast inhibitor (bisphosphonate) and has NOT developed ONJ

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Academic medical center(s)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01325142

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Indiana University
M.D. Anderson Cancer Center
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Catherine Van Poznak, MD University of Michigan
  More Information

No publications provided

Responsible Party: Catherine Van Poznak, Priniciple Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01325142     History of Changes
Other Study ID Numbers: HUM00040101, 5K23DE020197-02
Study First Received: March 28, 2011
Last Updated: December 1, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Michigan:
Osteonecrosis of the Jaw (ONJ)

Additional relevant MeSH terms:
Bisphosphonate-Associated Osteonecrosis of the Jaw
Bone Diseases
Neoplasm Metastasis
Osteonecrosis
Jaw Diseases
Musculoskeletal Diseases
Necrosis
Neoplasms
Neoplastic Processes
Pathologic Processes
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 28, 2015