SPOREsBreastCores
Activities: 1. Coordinate the review, preparation, and activation of all clinical studies in the SPORE.
2. Support all active SPORE clinical studies through: a. Recruitment and consent of patients to clinical studies b. Management and follow-up of patients on clinical studies c. Monitoring of accrual and toxicity, data management
3. Obtain consent for data collection, banking of tissue and blood specimens, and permission to re-contact for cohort studies in women with breast cancer and those women at high risk of developing breast cancer.
This Core facilitates all SPORE-related clinical research across the Dana-Farber Cancer Institute/Brigham and Women’s Hospital, Beth Israel Deaconess Medical Center, and Massachusetts General Hospital. These three institutions see over 4,000 new patients with breast cancer each year, and well over 15,000 patients are seen for ongoing therapy and/or follow-up visits. DF/HCC, a NCI-designated comprehensive cancer center, provides a linking structure for all three institutions.
All investigators in the Breast SPORE conducting clinical trials or other research studies involving human subjects use the Clinical Studies Core. These studies include those specifically identified in SPORE projects, as well as studies supported by the NCI-Avon Progress for Patients program.
The Core also provides support to selected non-SPORE DF/HCC investigators who are conducting trials that involve the acquisition of research biopsies. In addition, the Core identifies and obtains consent from patients for participation in our DF/HCC cohort studies, and research databases (Clinical Research Information System [CRIS] and Risk Evaluation and Cancer History [REACH]). The Core seeks to minimize delays in the activation of protocols, streamline patient recruitment, and consent studies across multiple institutions.
The work of this Core assures that clinical studies in the SPORE are conducted expeditiously and with rigor, enhancing the likelihood that the clinical trials and their linked laboratory-based research will be successful.
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