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

Completed

Conditions studied: Bone Diseases, Metastases, Osteonecrosis, Bisphosphonate-Associated Osteonecrosis of the Jaw

In brief

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

Key facts

Study ID

NCT01325142

Run by

University of Michigan

People needed

271

Starts

2010-08-01

Expected to finish

2014-11-01

Last updated by the study team

2014-12-02

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Insufficient specimen available to perform the assays proposed for specimen DNA analysis
• No accessable medical records

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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