Nontherapeutic Subject Registry (NTSR)

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Recruitment/Biospecimen and Data Collection and Distribution–Lombardi Research Participant Registry
This Resource will allow investigators from various disciplines, including behavioral scientists, clinical/translational researchers, epidemiologists and basic scientists, to have ready access to an Institutional Review Board (IRB) approved registry of individuals with cancer or at risk for cancer with high-quality baseline data linked to biospecimens, who have also consented to participate in  additional research.

NTSR recruiters have access to the MGUH scheduling systems; the available diagnostic information allows NTSR to identify and recruit subjects from clinics. The consent form includes separate consent for tissue, nontissue biospecimens, permission for re-contact by NTSR and other LCCC investigators, and medical record release.

The core questionnaire includes questions on basic demographic, cancer risk factors, quality of  life, and medical and family history. Based on responses to these core questions, subjects may be asked to complete supplemental questionnaires. Additionally, the questionnaire may be modified with various modules to include new questions.

Subjects are also asked if they agree to be contacted for existing and/or future research  opportunities, in which case they may be triaged into subsequent studies. Data are immediately entered into NTSR databases to allow for rapid triage into existing investigator studies.

Utilization of LRPR Data
De-identified data are made available to LCCC investigators.  LRPR data are especially useful in documenting feasibility of studies and as a means of characterizing the LCCC patient population, and can be incorporated into grant applications .

Subject Identification and Recruitment of LRPR Subjects into Subsequent Investigator-Initiated Studies.
LCCC investigators who require further subject contact must complete request forms, including documentation of IRB approval for their study. With every new study requiring subject contact, approval must first be given by the Recruitment Triage Committee. NTSR Managers Poggi and Finch query the LRPR database for subjects who have given permission to be re-contacted for additional studies and meet study-specific eligibility criteria. If participants consented to be contacted by LCCC investigators outside of the NTSR, names and
contact information are securely shared with investigators who then contact the participant  directly. The NTSR also provides investigators with LRPR core questionnaire data as requested. Investigators are required to send accrual updates to Poggi to track participant accrual. In addition, NTSR recruiters regularly review clinic schedules to determine if eligible subjects will be at LCCC in order to coordinate subsequent biospecimen collection as required by specific protocols.

Additional Protocol Support
At the request of investigators, NTSR recruiters are available to directly consent LRPR subjects onto study-specific protocols. NTSR personnel are also available to administer study-specific questionnaires when applicable.
Collection of Nontissue Biospecimens
When possible, NTSR recruiters obtain biological samples including blood, buccal swabs, hair, saliva, urine, and nail clippings which may be used in research studies. NTSR staff members ensure that meetings with eligible subjects coincide with regularly scheduled visits and attempt to coordinate phlebotomy procedures with standard medical procedures to minimize patient burden. Approximately 50 mL of blood are taken for the extraction of blood products including serum, plasma, buffy coat, red blood cells and blood clot. These products are processed and stored by the TCSR and are available as frozen aliquots. All other non-tissue biospecimens are collected on an as-needed basis and are stored with TCSR. Biospecimens can be collected at multiple time points so that biomarker levels can be measured before and after surgical and/or other treatment.

Collection of Tissue

Acquisition and investigation of fresh tumor tissue is a critical component of the LCCC research mission. In order to minimize redundancy of recruitment efforts across LCCC, the NTSR personnel work closely with the HTSR and Indivumed, a corporate  biorepository with an established collaboration with LCCC, to identify, consent and collect tissue for subjects undergoing surgical procedures at MGUH. This collaborative effort enhances the diversity and value of the biospecimens and data collected from these patients. Through the LRPR, the NTSR is able to collect de-identified tissue for investigator-driven projects.

Biospecimen Distribution.
De-identified samples and associated data are available to investigator. Investigators must complete request forms, including documentation that their study falls under the purview of NTSR IRB-approved protocols or that they have IRB approval for their study. Poggi and Finch then determine sample availability. In addition to the LRPR, the NTSR also oversees biospecimens from over 1800 sporadic cancer cases previously collected by the subsumed CMESR.

Recruitment/Biospecimen and Data Collection and Distribution--Familial Cancer.
Although the FCR as a Shared Resource no longer exists, maintaining and increasing our collection of familial cancer subjects remains an important component of the NTSR. Many (64%) of the patients seen through the genetic counseling programs at the Fisher Center and MedStar Washington Hospital Center (MWHC) agree to participate. In addition, LRPR subjects who report a significant family history of cancer or genetic testing outside of LCCC are flagged for participation. The collection’s data and biospecimens are highly valued because many subjects have undergone germline genetic testing for hereditary cancer. The NTSR provides investigators with access to one of the nation’s largest single-institution collections of individuals from high-risk cancer families, with a focus on high-risk breast and ovarian cancer families. The collection is an integrated and comprehensive resource that includes detailed questionnaire
data, medical history, cancer risk factors, tissue from surgeries (benign and malignant), tissue micro-array, EBV transformed cell lines and other blood products, all of which can be linked securely and confidentially to results of germline genetic testing results. The NTSR now has a bank of transformed cell lines from 1,475 high-risk subjects, and built five tissue microarrays (TMA) of tumor tissue from familial cancer patients. The NTSR collects baseline and annual
follow up questionnaires on familial cancer subjects. Family history information on all first- and second-degree relatives is collected as well.

 Database Development
In collaboration with BBSR and ICBI, NTSR uses Research Electronic Data Capture (REDCap) to build and manage data capture systems. REDCap is a web-based application that allows users to quickly, easily and securely build and manage online surveys. HTSR has also adopted REDCap, allowing for easy integration and sharing of data between the two Shared Resources for user requests and business needs. The adoption of a common data capture platform facilitates other LCCC informatics initiatives such as G-DOC by allowing for a standardized data format and coherent data architecture across multiple projects and organizations.

Data Entry
NTSR primarily utilizes REDCap for data entry projects, but also supports legacy software such as Microsoft Access and SQL Server databases. Quality controlled data records are linked by unique identification number to medical records and biospecimens. The  informatics manager can export data to investigators in a variety of formats, including SAS, SPSS, Stata, R, Excel, and text formats. If desired, investigators can directly extract their data on demand through the REDCap web interface

Medical Record Abstraction
Pathology reports and other related medical records are routinely abstracted for subjects who have consented to the release of such records to confirm reported diagnoses and procedures. Relevant data points are extracted from the reports and recorded in the corresponding  databases.

Consultation on Study Design and Project Planning
NTSR Codirectors and managers offer consultation services to LCCC members upon request. NTSR Codirector Isaacs, as Coleader of LCCC’s Breast Cancer Program (BC), provides a wealth of experience in this area. NTSR Codirector Peshkin’s expertise with recruitment procedures allows the NTSR to provide support for clinic implementation as well as questionnaire development. Peshkin’s genetic counseling expertise allows the NTSR to provide feedback on the integration of genetic counseling and testing during protocol planning. Manager Poggi offers IRB guidance and support for LCCC members who wish to utilize the NTSR, and for junior faculty members who desire support on unrelated protocols.