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

October 8, 2019 updated by: University of Michigan Rogel Cancer Center
This study will examine genes in three different tissues and look for similarities and differences between normal cells and cancer cells. The tissues to be studies come from blood, lymph node and cancer.

Study Overview

Status

Completed

Conditions

Detailed Description

Subjects will be given an informed consent to read and sign The medical chart will be reviewed for diagnosis and treatment history Blood (about 4 tablespoons) will be drawn at a clinically available time. The lymph node and breast tumor tissue in the University of Michigan pathology repository will be used for research purposes

Study Type

Observational

Enrollment (Actual)

149

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

breast cancer patients

Description

Inclusion Criteria:

  • Age at least 18 years of age
  • Able to read and sign the informed consent
  • Able to provide specimens: one blood draw for white blood cells, provide permission to use tissue already collected.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Single nucleotide polymorphisms
Time Frame: time-independent
Determine single nucleotide polymorphism concordances between the three DNA specimen sources
time-independent

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan Rogel Cancer Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

March 7, 2009

First Submitted That Met QC Criteria

March 9, 2009

First Posted (Estimate)

March 10, 2009

Study Record Updates

Last Update Posted (Actual)

October 10, 2019

Last Update Submitted That Met QC Criteria

October 8, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCC 2008.066
  • HUM 22831 (Other Identifier: IRBMED)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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