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.
- To evaluate the disease-free survival (DFS) in the two randomized arms after therapy with LC vs. EC in chemo-naive Her2-patients with stage I or II breast cancer
- To assess the overall survival (OS)
- To establish the safety profile by assessing the toxicities and tolerability
- To assess the quality of life (QoL)
- To evaluate survival correlation with biomarkers expression.
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.
Study design: Phase I trial assessing the safety, feasibility and toxicity of prophylactic NAC irradiation after nipple-areola sparing mastectomy and immediate reconstruction in patients with ductal carcinoma in-situ or invasive breast cancer.
Primary objective: To determine the recommended phase I dose of post-operative prophylactic NAC irradiation.
Secondary objectives: To provide extensive descriptive data regarding NAC-sparing surgery with reconstruction, including both surgeon experience and patient evaluation of cosmetic results. Survival and recurrence will be assessed.
Study size: Between 12 and 18 patients will be enrolled in this phase I study.
South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high rates of cardiovascular disease that is not explained by traditional cardiovascular risk factors. Though South Asians represent over one-quarter of the world's population, there are no longitudinal studies in this high-risk ethnic group. The investigators aim to establish a longitudinal study of South Asians at two United States centers to identify risk factors linked to subclinical atherosclerosis and incident cardiovascular disease. The purpose of this study is to understand the causes of heart disease and stroke in South Asians and compare these causes to those in other United States ethnic groups.