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

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT01325142
Collaborator
National Institute of Dental and Craniofacial Research (NIDCR) (NIH), Indiana University (Other), M.D. Anderson Cancer Center (Other), Memorial Sloan Kettering Cancer Center (Other)
271
Enrollment
1
Location
51
Duration (Months)
5.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    271 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer
    Study Start Date :
    Aug 1, 2010
    Actual Primary Completion Date :
    Nov 1, 2014
    Actual Study Completion Date :
    Nov 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. To generate a multifactorial index of ONJ risk by multivariate analysis of the clinical, epidemiologic and genetic factors [2009-2014]

      analysis is ongoing

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University of Michigan Ann Arbor Michigan United States 48109

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Catherine Van Poznak, MD, University of Michigan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Catherine Van Poznak, Priniciple Investigator, University of Michigan
    ClinicalTrials.gov Identifier:
    NCT01325142
    Other Study ID Numbers:
    • HUM00040101
    • 5K23DE020197-02
    First Posted:
    Mar 29, 2011
    Last Update Posted:
    Dec 2, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by Catherine Van Poznak, Priniciple Investigator, University of Michigan
    Osteonecrosis of the Jaw (ONJ)
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Bone Diseases
    Osteonecrosis
    Bisphosphonate-Associated Osteonecrosis of the Jaw

    Study Results

    No Results Posted as of Dec 2, 2014