Patients enrolled in clinical trials increasingly are receiving requests for tissue in the
informed consents for their studies or as a separate consent addendum. These studies
may require tissue samples to help identify the genetic or protein targets of an
investigational drug or to determine the characteristics of individuals who respond
best or who do not respond at all to the research agent. Such studies are referred to as “correlative studies.”
Correlative studies tend to be exploratory in nature. Depending on the clinical trial
design and other factors, they may require or request fresh tumor material, blood, or
urine. In addition, some might request a tissue sample from the patient’s FFPE tumor
block.
As noted above, different states vary in the length of time required for the archiving of
tumor blocks. Once this time lapses, many hospitals, particularly community
hospitals, discard the blocks to make room for new ones. Some research centers have
created “discarded block programs” that permit them to obtain such blocks for
research purposes, and many research hospitals never discard tumor blocks at all.
Extra Tissue Samples
Some studies will request additional biopsies. In such cases, researchers may request
access to the initial tissue sample (obtained during biopsy or surgery) and a second or
possibly additional tissue samples at later times based on specific criteria.