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Completed

NCT Number: NCT00897468

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

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.

medical chart review

Other

patient chart review will occur in conjunction with patient data collection for final analyses.

Primary outcomes

  1. Development of new in vivo models of human breast cancer

    Time frame: 1 year

  2. Correlation of response in this model to actual treatment outcome in patients, if the in vivo model proven feasible

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Developing In-Vivo Models of Human Breast Cancer

Important dates

Study start
2007
Primary completion
2018
Study completion
2018
First posted
May 12, 2009
Registry last updated
May 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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