Developing Mouse Models of Breast Cancer Using Tissue Samples From Women With Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Vanderbilt-Ingram Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00897468
First received: May 9, 2009
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

RATIONALE: Changing the genes in laboratory mice to create a living model of human breast cancer may help doctors learn more about breast cancer.

PURPOSE: This research study is developing mouse models of breast cancer using tissue samples that were previously collected from women with breast cancer.


Condition Intervention
Breast Cancer
Other: laboratory biomarker analysis
Other: medical chart review

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Developing In-Vivo Models of Human Breast Cancer

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Development of new in vivo models of human breast cancer [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Correlation of response in this model to actual treatment outcome in patients, if the in vivo model proven feasible [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: February 2007
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
breast cancer patients Other: laboratory biomarker analysis
Tissue samples will either be collected at the time of medically indicated surgical procedures or through research core biopsies. A sample of urine will also be obtained. Blood will be collected via venipuncture and lymphocytes (mononuclear cells) separated and processed as a source of normal DNA and normal cells.
Other: medical chart review
patient chart review will occur in conjunction with patient data collection for final analyses.

Detailed Description:

OBJECTIVES:

  • To develop new in vivo models of human breast cancer.
  • To correlate response in this model to actual treatment outcome in patients, if the in vivo model is proven feasible.

OUTLINE: Previously collected breast tumor fragments are implanted into the renal capsule site of SCID mouse hosts (mouse with severe combined immune deficiency) to establish metastatic spread patterns, and both histologic and molecular tumor characteristics.

Patients' medical charts are reviewed to obtain relevant information, including general demographics, smoking and alcohol use, as well as outcome data such as survival and response to treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

breast cancer patients

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of breast cancer

    • Any stage of disease
    • Primary or metastatic disease
  • Human breast tumor tissues available after the diagnoses have been made
  • Enrolled on the ongoing Breast Tissue Repository trial VU-VICC-BRE-03103

    • Have consented to the use of their tissues for research purpose
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  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: NCT00897468

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs Recruiting
Nashville, Tennessee, United States, 37064
Contact: VICC Clinical Trials Information Program    800-811-8480      
Principal Investigator: Bapsi Chak, MD         
Vanderbilt-Ingram Cancer Center at Franklin Recruiting
Nashville, Tennessee, United States, 37064
Contact: VICC Clinical Trials Information Program    800-811-8480      
Principal Investigator: Bapsi Chak, MD         
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center    800-811-8480      
Principal Investigator: Bapsi Chak, MD         
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Principal Investigator: A. Bapsi Chakravarthy, MD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: A Bapsi Chakravarthy, MD, Associate Professor; Radiation Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00897468     History of Changes
Other Study ID Numbers: VICC BRE 0704, P30CA068485, VU-VICC-BRE-0704
Study First Received: May 9, 2009
Last Updated: July 14, 2014
Health Authority: United States: Vanderbilt University Human Research Protection Program

Keywords provided by Vanderbilt-Ingram Cancer Center:
breast cancer

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

ClinicalTrials.gov processed this record on July 31, 2014