Clinical Studies Core The Clinical Studies Core will be involved in any SPORE study that requires patient consent, specimen acquisition, and/or protocol-based treatment. The core will provide an over arching structure within the SPORE and the Dana-Farber/Harvard Cancer Center that will eliminate the need to create individual project-based study teams in each of the clinical institutions. The Core will supply direct support to Projects 1, 2, 3, and 4. In addition, the Clinical Studies Core will obtain consent from all patients who are included in the cohort studies described in Core 3. Finally, the Clinical Studies Core will provide support to investigators to expedite the development, review, and activation of all clinical protocols.
The specific aims of the Clinical Studies Core are: ? To coordinate the review, preparation, and activation of all clinical studies in the SPORE ? To support all active SPORE clinical studies through: ? Recruitment and consent of patients to clinical studies ? Management and follow-up of patients on clinical studies ? Monitoring of accrual and toxicity, data management ? To obtain consent for data collection, banking of tissue and blood specimens, and permission to recontact for cohort studies in women with breast cancer and those women at high risk of developing breast cancer
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