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

May 3, 2018 updated by: A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

breast cancer patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Development of new in vivo models of human breast cancer
Time Frame: 1 year
1 year
Correlation of response in this model to actual treatment outcome in patients, if the in vivo model proven feasible
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Actual)

May 4, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC BRE 0704
  • P30CA068485 (U.S. NIH Grant/Contract)
  • VU-VICC-BRE-0704

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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