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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00858585
First received: March 7, 2009
Last updated: December 9, 2013
Last verified: December 2013
  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:


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

Primary Outcome Measures:
  • Single nucleotide polymorphisms [ Time Frame: time-independent ] [ Designated as safety issue: No ]
    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: January 2015
Estimated Primary Completion Date: June 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: University of Michigan 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: December 9, 2013
Health Authority: United States: Institutional Review Board

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

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 September 15, 2014