Tumor Biopsies in Clinical Trials
When tissue assays are recommended or mandated for trial participation, the PI must determine whether the tissue to be utilized will be obtained during the normal course of clinical care. If additional tissue is to be obtained solely for research purposes, then image guided biopsy must be included as a research procedure. This requirement holds even in cases where the additional tissue is obtained at the time of a clinically mandated procedure, provided that the tissue requirements for research result in additional tissue harvesting (additional surgical excision or additional needle biopsies) than would occur in the the course of routine clinical care.
The CIC can provide advice to clinicians regarding image guided biopsy services for research-directed tissue biopsy. For further information regarding this service, please see the Image Guided Biopsy Service (IGBS) information page