Kidney Cancer Journal 13
is that the CRC is positioned in the operating room during
interventional procedures that allow for tissue harvest
(nephrectomies, metastasectomies, image-guided
biopsies, and ablations). For many researchers and research
coordinators, clinical environments such as the
operating room are daunting. This perceived, and sometimes
real, barrier between the research environment and
clinical care settings can impede specimen collection efforts.
By being present in the operating room and interventional
radiology suite, the CRC is able to communi-
cate with the clinical staff to answer questions regarding
specimen acquisition, record critical pre-analytic variables,
and coordinate with research teams waiting to receive
the specimens. If needed for a particular assay, our
CRC’s are also able to process specimens utilizing skills
acquired from past laboratory bench-based research experience.
This allows for highly specialized collection
protocols that extend our capacity beyond traditional tissue
banks.
Due to this unique hybrid position, we believe the
CRC must be an individual who is capable of bridging
the gap between the research laboratories using the tissue
specimens and the clinical environments from which the
specimens are acquired. Most importantly, the CRC must
be skilled in communicating with patients with cancer
and their families, so they do not incur additional stress
during their treatments. The CRC also must build collegial
relationships with both medical and research staff,
and maintain familiarity and competence in clinical environments
like the operating room and gross pathology
work room.
In order for a CRC to be effective in this role, he or
she must be given the tools to operate with a high degree
of independence. Such tools include access to the clinical
environments where patients can be consented and tissues
can be obtained (clinics, operating rooms, pathology
gross rooms, interventional radiology suites, and hospital
wards), and access to resources to identify potential cases,
look up surgery times and patient visits, acquire clinical
data on research patients, and perform proper research
documentation. We have had CRCs shadow PIs in the
operating room during training, and work with the PI in
the pathology gross room to acquire tissue specimens
until the CRC becomes comfortable performing these duties
independently. Similarly, the CRCs have shadowed
PIs in the urologic and medical oncology clinics, learning
about the patient experience as well as relevant kidney
cancer biology and treatment courses. The Stanford Cancer
Clinical Trials Office (CCTO) has provided training
for the regulatory affairs aspect of the CRC’s duties. The
training in regulatory affairs and conduct of research that
a CCTO can provide is invaluable in ensuring that a
biospecimen harvesting research protocol is legally and
ethically compliant.
Research Scientists
The basic scientists and laboratories involved in the Stanford
Kidney Cancer Research Program are the end users
of the tissue specimens acquired, and are actively involved
in this prospective collection model. Research laboratories
interested in studying RCC approach either the
PI or CRC with clinically relevant hypotheses, and propose
the biospecimens that would be required to test
them. In doing so, the research scientists provide crucial
information regarding acquisition, processing, and storage
conditions required to maintain the fidelity of the
specimens and eliminate variability in the research assays
for which they will be used. In this way, basic scientists
at our institution play an integral role (along with the
CRC) in designing tissue acquisition protocols. We have
had success designating a single member of the research
team to act as a point of contact for the CRC. We also
encourage discussion of protocols and strategies in our
bi-weekly Stanford Kidney Cancer Research Program conference.
This allows for the pertinent information regarding
the specimen needs of the laboratory to be com-
municated, and allows the CRC to help identify upcoming
cases or clinical encounters to quickly satisfy the
group’s tissue needs with specimens acquired under the
optimal conditions. We have found that this level of
communication allows the CRCs to provide specialized
collection services not available through our institutional
programs (e.g. collection of fresh tissue using core or
fine-needle aspirate biopsies, multi-region tissue sampling,
or collections in specific medium required for experiments).
Moreover, this level of access to specimens
has assisted with recruiting cancer biology laboratories
to study RCC, as they often face challenges in acquiring
biospecimens when studying other cancer types.
Clinicians
Treating patients with RCC requires a team that includes
surgeons, oncologists, interventional radiologists, radiologists,
and pathologists. Our research team involves all
interested clinicians from these disciplines to maximize
the acquisition of specimens, and increase the likelihood
of acquisition of rare specimens. To do this, we have included
multiple urologists and medical oncologists as
study co-investigators on specimen acquisition protocols.
Our protocol also includes pathologists as co-investigators
to assist with the acquisition of tissue specimens
from the gross room and re-review of histology when
necessary. We encourage clinicians to also attend the
aforementioned bi-weekly meetings to discuss research
in progress. This has fostered trust among clinicians such
that they feel comfortable in approaching their patients
for enrollment to the studies, and are willing to participate
in biospecimen collection even if it requires additional
time and effort.
Designing Multi-Modal Biospecimen
Collection Research Protocols
We have worked with the IRB to create protocols that
allow collection of multiple specimen types (e.g. tissue,
blood, and urine) at serial timepoints throughout the patient’s
clinical course. In order to obtain permission to