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

NCT ID: NCT01325142

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

271 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2014-11-30

Brief Summary

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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

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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

Conditions

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Bone Diseases Metastases Osteonecrosis Bisphosphonate-Associated Osteonecrosis of the Jaw

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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ONJ

Patient with cancer involving the bone treated with osteoclast inhibitor (bisphosphonate) and has developed ONJ

No interventions assigned to this group

No ONJ

Patient with cancer involving the bone treated with osteoclast inhibitor (bisphosphonate) and has NOT developed ONJ

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Catherine Van Poznak

Priniciple Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Catherine Van Poznak, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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5K23DE020197-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00040101

Identifier Type: -

Identifier Source: org_study_id