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:
Vanderbilt-Ingram Cancer Center
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: April 10, 2013
Last verified: April 2013
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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: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (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
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: | April 10, 2013 |
| 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 May 16, 2013