CompletedNot Applicable

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

United States271 participantsStarted 2010-08

Plain-language 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.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To identify clinical and epidemiologic characteristics associated with ONJ in patients with metastatic bone disease treated with a nitrogen containing bisphosphonate.

Timeframe: 2009-2014

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.

Timeframe: 2009-2014

To generate a multifactorial index of ONJ risk by multivariate analysis of the clinical, epidemiologic and genetic factors

Timeframe: 2009-2014

Trial details

NCT IDNCT01325142

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2014-11

View on ClinicalTrials.gov More Bone Diseases trials

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

To identify clinical and epidemiologic characteristics associated with ONJ in patients with metastatic bone disease treated with a nitrogen containing bisphosphonate.

Timeframe: 2009-2014

To generate a multifactorial index of ONJ risk by multivariate analysis of the clinical, epidemiologic and genetic factors

Timeframe: 2009-2014