Molecular Analysis of Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of California
California Breast Cancer Research Program
Breast Cancer Research Foundation
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00569049
First received: December 4, 2007
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

This is a research-based study that is looking at the biologic features of breast tissue, lymph node tissue, or blood in order to study breast cancer development growth, and spread. Through tissue and/or blood samples we hope to gain further knowledge and understanding of how to improve diagnosis and treatment of breast cancer by identifying the molecular markers that predict clinical outcome and response to therapy.


Condition Intervention
Breast Cancer
Breast Cancer Non-invasive Breast Cancer
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Procedure: breast tissue, lymph node tissue or blood

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Analysis of Breast Cancer

Resource links provided by NLM:


Further study details as provided by Stanford University:

Biospecimen Retention:   Samples With DNA

tumor, normal tissue and blood


Estimated Enrollment: 99999
Study Start Date: May 1996
Estimated Primary Completion Date: May 2050 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: breast tissue, lymph node tissue or blood
    Molecular Analyses of samples
Detailed Description:

The tissue obtained in this protocol will be used for genome-wide examination of DNA, RNA expression profiling, proteomic analyses, isolation and analyses of normal and cancer stem cells, isolation and analyses of circulating tumor cells, possible analyses of immune cells, and possible analyses of serum factors. The tissue may also be used to develop patient-specific cell culture models or mouse xenograft models of breast cancer for biologic study of tumor progression and metastases and for therapeutic testing. In general, the tissue will be used in studies that will molecularly classify tumors, identify prognostic markers, identify potential therapeutic markers, identify potential treatment targets, and help us better understand the biology and specific role played by different tumor cells in the metastatic process.

The ultimate goal is to use molecular analyses to improve the diagnosis and treatment of breast cancer.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

patients undergoing breast cancer procedures

Criteria

Inclusion Criteria:People eligible for this study include anyone older than 18 years who is undergoing one of the following procedures: core needle or surgical breast biopsy, lumpectomy, mastectomy, axillary lymph node surgery, breast reduction surgery, or ductal lavage or ductoscopy. Patients who have had breast cancer in the past who are currently free of disease or who have a breast cancer recurrence are also eligible. All patients who participate must be able to understand and sign the informed consent. Although most patients will be female, any males undergoing the above procedures are also eligible for this study.

Exclusion Criteria:Any patient who is less than 18 years old, who is unable to understand the informed consent, or not undergoing the above procedures will be excluded from this research.

  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: NCT00569049

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
University of California
California Breast Cancer Research Program
Breast Cancer Research Foundation
Investigators
Principal Investigator: Stefanie S. Jeffrey M.D. Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00569049     History of Changes
Other Study ID Numbers: SU-11052007-799, 1028313-100-JAACC, 1045090-101-KBAHQ, 10EB-10086; 11IB-0175, 75026, 8EB-1106, BRSNSTU0001, CA085129; 1R01CA109325-01
Study First Received: December 4, 2007
Last Updated: April 4, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014