collect different types of biospecimens in a single protocol,
we have designed a “check box system”. With this
system, a patient can opt in or out of providing certain
biospecimens by initialing next to each procedure outlined
in the consent. This gives patients the flexibility to
participate in ways that they are most comfortable. For
example, a patient may consent to donating tissue harvested
after a surgery is complete, but not consent to
blood collection at the time of surgery. We have found
that the check box system in our consent reduces patients’
anxiety associated with participating in the research
study, and has increased our accrual.
Our comprehensive approach to collecting specimens
has also provided the opportunity for some less common
tissue collection strategies not available through generalized
banking programs like the Stanford Tissue Bank.
For example, a radical nephrectomy specimen could provide
multi-region sampling as well as an 8mm core biopsy
for preparation of xenograft models. Similarly, our
prospective approach facilitates blood collections during
routine clinical draws as well as research-only collections.
Practical Aspects of Specimen Acquisition
Though aspects of a biospecimen acquisition protocol
will vary by institution and by research question, it is
universally necessary for the specimens acquired to be
collected in a way that minimizes artifact and preserves
their biology to the highest degree possible, and that all
aspects of collection are documented. An additional benefit
of positioning a dedicated CRC where the specimen
is collected is that it affords the research team the ability
to record and systematically test critical pre-analytic variables
that may influence the fidelity of the specimen.
These include patient-level factors (e.g. specific comorbidities,
prior RCC treatments), as well as pre-analytic
variables specific to the procedure and tissue of interest
(e.g. warm ischemia time, blood loss or hypotension during
the procedure, the stabilization media used, transport
and storage temperature, processing time).5 To
accomplish this, the CRC carries a tissue harvesting kit
to every case. The kit contains the required specimen
preparation tools, but also specialized methods for documenting
collection efforts, such as marking pins to denote
the region where tissue is harvested from during
multi-region sampling, as well as a camera to capture relevant
images of the tissue harvest that can be utilized
later to identify areas of gross necrosis, fibrotic tissue,
and variant histology. Figure 2 illustrates some aspects
of biospecimen collection, and how a surgical sample
could be processed for inclusion in multiple studies such
as a RCC tissue microarray,9,10 multi-region proteomic
sampling,11 larger core biopsies for patient-derived xenografts,
12-17 or for bulk tissue acquisition for organoids and
other larger-scale models and analyses.18 Utilizing this
approach, we have acquired specimens from 360 resected
RCC tumors, with multi-region sampling in 312 cases.
We also collect paired normal tissue in all cases when
possible.
14 Kidney Cancer Journal
Figure 2. An example of multi-modal collection for a radical
nephrectomy specimen.
Similarly, we prefer the CRC to also be present in the
endoscopy and radiology suites throughout procedures
involving image-guided biopsies. By being present in this
way, the CRC can ensure that the specimen is properly
labelled if taken from multiple locations, acquired and
stored in the proper medium, and that aspects of the acquisition
are documented (e.g. core vs. fine needle aspiration).
19 The actual presence of the CRC during the
biopsy also assures that any questions that arise regarding
the research specimens can be immediately addressed,
increasing the rate of successfully acquired
research biopsies. To date, we have acquired tissue specimens
using CT, ultrasound, or endoscopic guidance
from 26 participants.
Because clinical and research blood draws can occur
in multiple laboratories and even multiple campuses, it
is not possible for the CRC to be present for each blood
collection in the same fashion. To ensure that research
collections occur regardless of the location, the CRC coordinates
and facilitates the placement of research blood
draw orders in the patient’s electronic medical record. A
research blood draw kit is assembled with blood collection
tubes specific to the needs of each assay. With the
orders is a set of instructions provided to the phlebotomist
or nurse drawing the blood, which details the
conditions under which the blood should be stored, and
instructs the person drawing the blood to record the
draw time and page the CRC as soon as the blood is
drawn so time-sensitive samples can be processed
quickly. With this coordinated effort, blood can be collected
and distributed to multiple laboratories investigating
different aspects of RCC. Examples of specialized
studies using blood collections include the isolation of