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

This study is currently recruiting participants.

Verified April 2013 by Vanderbilt-Ingram Cancer Center

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center

ClinicalTrials.gov Identifier:

NCT00897468

First received: May 9, 2009

Last updated: April 10, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

May 9, 2009

Last Updated Date

April 10, 2013

Start Date ^ICMJE

February 2007

Estimated Primary Completion Date

March 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00897468 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Developing In-Vivo Models of Human Breast Cancer

Brief Summary

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.

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 ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

breast cancer patients

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

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.

Study Group/Cohort (s)

breast cancer patients

Interventions:

Other: laboratory biomarker analysis
Other: medical chart review

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2014

Estimated Primary Completion Date

March 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00897468

Other Study ID Numbers ^ICMJE

VICC BRE 0704, P30CA068485, VU-VICC-BRE-0704

Has Data Monitoring Committee

Responsible Party

A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center

Study Sponsor ^ICMJE

Vanderbilt-Ingram Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

A. Bapsi Chakravarthy, MD

Vanderbilt-Ingram Cancer Center

Information Provided By

Vanderbilt-Ingram Cancer Center

Verification Date

April 2013

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

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