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

This study is currently recruiting participants.

Verified August 2011 by University of Michigan Cancer Center

First Received on March 7, 2009. Last Updated on August 8, 2011 History of Changes

Sponsor:	University of Michigan Cancer Center
Information provided by:	University of Michigan Cancer Center
ClinicalTrials.gov Identifier:	NCT00858585

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:	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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Osteonecrosis

U.S. FDA Resources

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

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:	January 2015
Estimated Primary Completion Date:	June 2012 (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

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858585

Contacts

Contact: Cancer Answer Line

1-800-865-1125

Locations

United States, Michigan
University of Michigan	Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Cancer Answer Line 800-865-1125 canceranswerline@umich.edu
Contact: Catherine Van Poznak, M.D. 734 6125 2109 cvanpoz@umich.edu
Principal Investigator: Catherine Van Poznak, MD

Sponsors and Collaborators

University of Michigan Cancer Center

Investigators

Principal Investigator:

Catherine Van Poznak, MD

University of Michigan Cancer Center

More Information

No publications provided

Responsible Party:	Catherine Van Poznak, M.D., Umiversity of Michigan Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00858585 History of Changes
Other Study ID Numbers:	UMCC 2008.066, HUM 22831
Study First Received:	March 7, 2009
Last Updated:	August 8, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Michigan Cancer Center:

Bone metastasis

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasm Metastasis
Osteonecrosis
Neoplasms by Site
Neoplasms
Breast Diseases

Skin Diseases
Neoplastic Processes
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Necrosis

ClinicalTrials.gov processed this record on February 09, 2012