Patient Derived Breast Cancer Xenografts
This study will use tissue or body fluid acquired during standard procedures that are part of the patient's care for their cancer, such as surgery to remove tumor tissue or needle withdrawal of body fluid containing cancer cells. The tissue or cells will be injected into immune compromised mice and the tissue will be allowed to grow to a tumor 1-1.5 cm size. The tissue will then be extracted and either frozen, embedded in paraffin, or used for engraftment into another generation of mice. The second generation mice will be separated into groups and given various treatments.
Tissue from the participants and from the mouse established tumors, in which the mice have either received treatment or have not received treatment, will be used to evaluate the levels of various genes that assist in regulating cell growth and cell death. The tumor tissue from participants and mice will also be tested for random changes in the genetic material and compared to the participant's blood to determine if any of the changes in the genetic material correlate with better engraftment of the patient tissue in the mice. It is anticipated that 10-30% will have successful engraftment of tumor tissue
Metastatic Breast Cancer
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Patient Derived Breast Cancer Xenografts|
- Successful Engraftment [ Time Frame: 2 years ] [ Designated as safety issue: No ]Thirty-five patients with breast cancer will be recruited. We anticipate that 10-30% will have successful engraftment of tumor tissue. The achievement of five successful xenografts would justify additional study.
- Time until tumor formation [ Time Frame: 2 years ] [ Designated as safety issue: No ]The rate of tumor growth will be calculated. Mice are monitored three times per week for general health and tumor length. Tumor length Tumor length and width are measured with calipers and recorded. Tumor volume will be calculated with the formula (Length x Width x Width)/2, derived from the formula for the volume of an ellipsoid. Tumor growth will be measured at each time point by calculating the ratio of tumor volume (V) to the initial tumor volume (Vo). Average time, measured in weeks, required for tumors to form palpable masses in F1 mice will be recorded as the Time-until-Tumor-Formation (TTF). A comparison of TTF between tumor cells isolated from tumor tissue isolated by surgical biopsy, and by malignant cells in a body fluid will be compared
Biospecimen Retention: Samples With DNA
whole blood and tumor tissue samples as well as DNA that has been extracted from both blood and tiisue will be stored.
|Study Start Date:||December 2013|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Invasive breast cancer with metastatic disease|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750164
|United States, New Hampshire|
|Dartmouth Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|Principal Investigator:||Gary Schwartz, MD||Dartmouth-Hitchcock Medical Center|