Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. We have both interventional & observational types of clinical trials found on this site.
MicroRNAs (MiRNAs) regulate the translation of RNAs and are implicated in cell proliferation and renewal both under physiologically normal as well as in malignant conditions. Dysregulation of specific miRNAs may be associated with either gaining oncogenic or loosing tumor suppressing functions. MiRNA dysregulation has been implicated in breast cancer tumorigenic (stem cell) and non-tumorigenic development. Therefore, miRNA profiling of treatment naïve and treatment-exposed breast tumors and sequential samples of blood/serum will allow for identification of miRNA markers of prognosis and as indicators and potential targets for personalized therapies. In this proposal, specimens from patients treated in the clinical breast cancer program on already existing protocols (IRB 05091 and 05015) will be characterized by Dr. Rossi's laboratory and collaborators, and the information gained will be applied to develop specific therapies.
Insulin resistance is a crucial factor for the development of type 2 diabetes and a major
health problem for older adults. It is the principal mechanism by which obesity is considered
to increase the risk for type 2 diabetes and is a key feature of the metabolic syndrome. The
elevated prevalence of obesity and type 2 diabetes in the older population has important
consequences on the morbidity and mortality as well as on the economic burden on society.
Controversy currently exists as to whether or not aging contributes to insulin resistance.
Many potential factors confound the association between aging and insulin resistance,
including obesity and physical inactivity.
Ectopic lipid depositions, defined as an excess accumulation of triglycerides in non adipose tissues such as in the liver (intrahepatic lipids) and within the muscle fibers (intramyocellular lipids), are positively associated with obesity and insulin resistance. Furthermore, the accumulation of intracellular lipids is often cited as being a key determinant in the underlying mechanisms of insulin resistance. In addition of playing an important role in obesity and type 2 diabetes, these ectopic fat depositions are also observed in common conditions such as aging and physical inactivity.
The intervention trial will test in skeletal muscle, liver and heart of sedentary obese volunteers, normal weight volunteers and masters athletes, the overall hypotheses that exercise improvement of fat oxidation capacity and/or decrease of damaging fat metabolites is a primary factor that predicts the improvement in insulin resistance.
Overall rationale: Prophylactic NAC irradiation after nipple-areola sparing mastectomy and
immediate reconstruction for patient with ductal carcinoma in-situ or invasive breast cancer
will allow better cosmesis and patient's satisfaction:
- The use of NAC-sparing mastectomy followed by postoperative NAC (nipple-areola complex) external beam radiotherapy for selected patient with early stage invasive or in-situ breast cancers will be technically feasible and with acceptable complication rates.
- The cosmetic results after NAC-sparing mastectomy followed by postoperative external beam radiotherapy to the NAC will be better comparable with Skin Sparing Mastectomy.
- The local control rate in the NAC will be more than expected for a NAC sparing mastectomy without postoperative radiotherapy.
- The patient's satisfaction after NAC-sparing mastectomy followed by postoperative NAC external beam radiotherapy will be better than after Skin Sparing Mastectomy.