Kidney Cancer Journal 15
Figure 3. Example screenshot from our REDCap database. A) Research data is
organized into instruments that include enrollment/regulatory data, clinical
data, and specimen data. B) Customizable reports allow for specific data to
be queried, shared, or exported for analysis. C) Pre-analytical variables for
specimen collection can be included for each specimen. D) Media storage
allows for attached photographs of specimens, or clinical image files to be
attached for each specimen. E) The description of the photo can be included
to note specimen characteristics.
circulating tumor cells, plasma banking and cryopreservation
of PBMCs, and the development of novel bloodbased
diagnostic assays. Our protocols also allow for
blood to be collected at serial time points, with specimens
being collected at the time of routine clinical lab
testing, drawn from intravenous ports or lines at the time
of treatment or surgery, and dedicated research-only
blood sampling that is independent of a routine lab
draw. Together, these efforts have resulted in a repository
of 1084 total blood samples collected from 344 participants
(312 patients with RCC; 32 non-cancer controls),
with 227 patients contributing serial samples throughout
the course of their treatment.
Data Management
Equally as important as strong personnel and well-written
protocols is a means by which to organize the
tremendous amount of data collected. At Stanford, we
utilize three databases in our research effort: a patient
enrollment database, an institutional RCC clinical database,
and a specimen database. Each resource has a specific
purpose to meet the needs of the Kidney Cancer
Research Program. Most importantly, all are encrypted
and secured, allowing for the storage of Protected Health
Information crucial to the clinical and translational
aspects of the research effort.
Enrollment Database
The enrollment database tracks the screening,
consent, enrollment, and withdrawal of
patients from research protocols. The Stanford
Cancer Institute utilizes OnCore v14.2
(Forte Research Systems, Madison, WI) as
the enrollment database. This resource assigns
each participant a study ID for specimen
tracking and blinding, integrates with
the electronic health record to pull participant
demographic information, records
when patients were consented and with
what version of the protocol, and can track
survival outcomes. It also allows for researchers
to record if patients withdraw
from the study and for what reason, along
with any adverse events that may have occurred
as part of the research procedures. We
are proud to report that no patients have incurred
adverse events as a result of participating
in our specimen collection research
protocols.
Institutional Renal Cell
Carcinoma Clinical Database
The Stanford Renal Cell Carcinoma Database
(RCCD), is a medical center database
consisting of clinical, demographic, and
outcomes data for all patients with RCC
treated at Stanford from 2003 to the present.
Participant data is entered into the RCCD
through an automated process, and is then curated to
ensure data quality. Variables include date of diagnosis,
date of surgery, clinical staging, pathologic staging,
pathologic features, dates and types of treatment received,
response to treatment, patient performance status,
adverse events, and date of death.
Specimen Database
The specimen database is specific to our RCC specimen
acquisition efforts, and is designed to track all the parameters
of the samples collected using the research protocols.
This database is constructed using Research
Electronic Data CAPture (REDCap, https://www.projectredcap.
org), a HIPAA-compliant secure web application
designed to support data capture for research studies,
provide an intuitive interface for validated data entry,
and audit trails for tracking data manipulation and export
procedures.20 Stanford maintains a version of REDCap
that restricts access to users with active Stanford
login credentials accessing REDCap from an on-campus
computer or Stanford VPN, as well as project-specific user
access to protect research information. REDCap is also
approved for research for Veterans participating through
the VA Palo Alto Health Care System. Within REDCap,