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

Tracking Information
First Submitted Date	May 9, 2009
First Posted Date	May 12, 2009
Last Update Posted Date	May 4, 2018
Study Start Date	February 2007
Actual Primary Completion Date	May 2018 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: April 10, 2013)	Development of new in vivo models of human breast cancer [ Time Frame: 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 ]
Original Primary Outcome Measures; (submitted: May 9, 2009)	Development of new in vivo models of human breast cancer; Correlation of response in this model to actual treatment outcome in patients, if the in vivo model proven feasible
Change History	Complete list of historical versions of study NCT00897468 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Developing Mouse Models of Breast Cancer Using Tissue Samples From Women With Breast Cancer
Official Title	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	Observational
Study Design	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	Breast Cancer
Intervention	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 Groups/Cohorts	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	Completed
Actual Enrollment; (submitted: May 15, 2017)	26
Original Enrollment	Not Provided
Actual Study Completion Date	May 2018
Actual Primary Completion Date	May 2018 (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT00897468
Other Study ID Numbers	VICC BRE 0704; P30CA068485 ( U.S. NIH Grant/Contract ); VU-VICC-BRE-0704
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
Study Sponsor	Vanderbilt-Ingram Cancer Center
Collaborators	National Cancer Institute (NCI)
Investigators	Principal Investigator: A. Bapsi Chakravarthy, MD Vanderbilt-Ingram Cancer Center
PRS Account	Vanderbilt-Ingram Cancer Center
Verification Date	May 2018