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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00858585
First Posted: March 10, 2009
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Michigan Cancer Center
  Purpose
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.

Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer: Concordance Study

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • Single nucleotide polymorphisms [ Time Frame: time-independent ]
    Determine single nucleotide polymorphism concordances between the three DNA specimen sources


Biospecimen Retention:   Samples With DNA
Retained samples will consist of a portion of the specimens collected for this concordance study: peripheral blood leukocytes, lymph nodes, and tumor tissue. All retained samples will be completely de-identified and re-numbered.

Estimated Enrollment: 120
Study Start Date: March 2009
Estimated Study Completion Date: September 2017
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
breast cancer patients
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00858585


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Catherine Van Poznak, MD University of Michigan Cancer Center
  More Information

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00858585     History of Changes
Other Study ID Numbers: UMCC 2008.066
HUM 22831 ( Other Identifier: IRBMED )
First Submitted: March 7, 2009
First Posted: March 10, 2009
Last Update Posted: March 3, 2017
Last Verified: March 2017

Keywords provided by University of Michigan Cancer Center:
Bone metastasis, SNP concordance

Additional relevant MeSH terms:
Neoplasm Metastasis
Osteonecrosis
Neoplastic Processes
Neoplasms
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Necrosis