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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

May 9, 2009
July 14, 2014
February 2007
January 2015   (final data collection date for primary outcome measure)
  • 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 ]
  • Development of new in vivo models of human breast cancer [ Designated as safety issue: No ]
  • Correlation of response in this model to actual treatment outcome in patients, if the in vivo model proven feasible [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00897468 on ClinicalTrials.gov Archive Site
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Developing Mouse Models of Breast Cancer Using Tissue Samples From Women With Breast Cancer
Developing In-Vivo Models of Human Breast Cancer

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

breast cancer patients

Breast Cancer
  • 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.
breast cancer patients
Interventions:
  • Other: laboratory biomarker analysis
  • Other: medical chart review
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
July 2015
January 2015   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
United States
 
NCT00897468
VICC BRE 0704, P30CA068485, VU-VICC-BRE-0704
No
A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Principal Investigator: A. Bapsi Chakravarthy, MD Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP