BioRepository And Precision Pathology Center (BRPC)

The BioRepository & Precision Pathology Center (BRPC) was created to provide Duke with a shared resource for coordinated tissue processing and biorepository services in a CAP/CLIA accredited environment. The BRPC provides services that include patient identification and informed consent, specimen collection, processing and banking and annotation of banked specimens and specimen distribution. The consolidation of biobanking into a single infrastructure represents an opportunity to ensure:

• High quality biospecimens,
• Global institutional compliance with CAP and FDA regulations around biobanking and associated research,
• Maximization of biospecimen utility, and
• Global and equitable access to investigators.

The BRPC is based in the Department of Pathology, has dedicated staff, and is under the direction of Shannon McCall, PhD. Primary customers of the BRPC are the Disease-Specific Working Groups of the Duke Cancer Institute (DCI), who govern collection priorities and distributions for their groups. With the BRPC, all DCI members have access to robust, gold-standard biobanking and protocol development services and, with the approval by the relevant disease-site group, to use of human biospecimens relevant to a wide range of cancers.

The BRPC functions under a single IRB protocol focused on banking "excess" and limited "additional" specimens for research. “Excess tissue” can be immediately obtained in conjunction with surgical resections through our close association with the Department of Pathology. "Additional tissue" may also be safely obtained during biopsy procedures in which the patient has consented for an additional biopsy to be taken for research. Concordance between research and diagnostic biopsy samples is ensured by our pathology staff. Patients will also consent to have their medical record accessed by BRPC staff for limited sample annotation.

Our group provides biospecimen inventory management of frozen samples, paraffin-embedded samples, fractionated blood components, daughter specimens, and derived specimens including DNA and RNA. As part of our CAP-accreditation and association with the Department of Pathology, every solid tissue specimen we bank is histologically verified with annotation of tumor content and digital photographic documentation.

Submit A Request

BRPC Request For Protocol Support
To request continuous BRPC services for a protocol, please complete the form and email to melissa.flowers@duke.edu. Download Form

BRPC Request For Samples or Data
To request existing BRPC samples or associated data, please complete this form and email to BRPC@duke.edu. Download Form

Clinical Trial Pathology Materials
To request individual pathology materials (e.g. slides, etc.) for Clinical Trial Enrollment/ Eligibility, please complete the form and email to path-clintrials@duke.edu. Please note there is a fee associated with these requests. Download Form

• Full-service biobanking from informed consent to nucleic acid extraction
• Serves the biobanking needs of Disease-Site groups of the DCI
• Consultation on new protocols involving tissue
• Cost-effective and rapid access to de-identified tissues for proof-of-concept studies
• Complete integration with Surgical Pathology at Duke
• Histologic verification of every banked specimen
• Prestigious College of American Pathologists Biorepository Accreditation ensures quality and patient safety.
• End-user access via email, website forms, and 24-hour pager

• Cryogenic storage: Liquid nitrogen storage tank (one), −80ºC freezers (five)
• Sensaphone Remote Temperature Monitoring System of 161 ft3 of cryogenic storage space
• Histology: Paraffin tissue processor, embedding station
• Nucleic Acid Quality assurance: NanoDrop® ND-1000, gel documentation system
• Specimen Identity: barcode printers, paraffin block printers and barcode readers
• Archiving: Digital photomicrograph station, paraffin and slide storage system
• Safety: Biosafety cabinet, flammables storage

DCI Disease-specific Working Groups Are the Customers of the BRPC

The BRPC is helping the DCI disease-specific working group develop their own individual tissue repositories using a centralized and common infrastructure. These repositories are "owned" and governed by these working groups and banking priorities and specimen release is regulated under their governance, by a governance body. Each governance body should include representative of all areas of practice (surgeons, oncologists, pathologists, and basic scientists). Requests for tissue banking or tissue release should be submitted through your DCI working group; more specifically through your group's governance body. Governance bodies receive, evaluate, and approve requests from members of their working group before submitting requests to the BRPC for processing. If your discipline's working group has not established a governance body, please take this opportunity to discuss this banking project with your working group leader. A list of disease-specific working group leaders is provided below.

Banking Requests

Once tissue banking priorities have been established through your group's governance body, your group should identify patients to meet your banking needs. These may be patients who are being seen in your clinics or by your group's surgeons, oncologists, or radiologists. The BRPC can only consent patients and bank their tissue if the patient has an upcoming scheduled diagnostic procedure or surgery where tissue will be also be obtained for clinical purposes. Some groups have added nurses or clinical research staff to the BRPC protocol to aid in the consenting process (described below). Notification to the BRPC of a request for banking can be made using our banking request form. A banking request form is available with instructions. To have the BRPC successfully bank tissue the BRPC requires:

• The name of the patient and the patient's Duke MRN (required),
• The patient's appointment time and location and who the patient will be seeing for their appointment (required),
• The patient's scheduled procedure date and primary diagnosis (if known), and
• Whether the patient needs to be consented to this protocol by the BRPC staff or if your working group plans on handling the consent for your patient.

Consenting Mechanisms

Consent for tissue collection can occur in two ways.

• A BRPC staff member consents the patient. BRPC staff, upon receipt of a banking request form indicating the need for consent, will identify an appropriate time and place for pre-operative consent based on the patient's upcoming appointment schedule. If rapid same day patient identification and consent is required, BRPC staff can be alerted by pager: 919.970.4731. However, we cannot guarantee availability with less than 24 hour notification.
• Individuals from disease-specific working group consents the patient. Qualified individuals from the disease-specific working group may be trained on consenting and added to the BRPC protocol. Once trained, these individuals, if part of the clinical practice, can consent patients in a manner that is most convenient for the workflow of physicians in the clinic.

Contact the BRPC Staff or at 919.684.6928 for more information about option 2, or to request a training session for consenting on the BRPC protocol.

Two Different Consent Forms

Consent for the BRPC protocol can be obtained using two different consent forms.

• Excess tissue consent: Consent of patients using the excess tissue consent form allows for the banking of excess tissue that would otherwise not be used for diagnosis. Example: excess tissue is banked for research after a surgical resection of a large primary lung carcinoma in which only a small amount of tumor would be used by the anatomic pathologists to render a diagnosis.
• "Additional" tissue consent form: This consent allows banking of material from additional passes during a diagnostic biopsy procedure. Example: additional needle core biopsies of a breast mass.

Both of the above consent forms:

• Will be scanned into the patient's medical record and placed under the "Media" tab in Maestro Care,
• Will allow for future "excess" tissue banking from subsequent procedures related to the same diagnosis, and
• Will allow for the option of peripheral blood collection, provided the patient agrees.

It is important to note that every "additional" tissue collection from the patient solely for banking requires a new consent event.

Services Rendered and Tissue Release

In addition to banking tissue, BRPC staff will also provide the following services:

• Provide a Hematoxylin and Eosin (H&E) stain on banked tissues.
• Have these H&E's reviewed by a board-certified pathologist with clinical privileges at Duke Hospital.
• Correlate the histologic findings with the histologic finding for the associated clinical diagnostic case for the patient.
• Ensure that the tissue banking event does not interfere with the quality or accuracy of the diagnosis rendered for the clinical diagnostic case for the patient.
• Return banked tissue to the clinical case for the patient if required for accurate diagnosis.
• Process a piece of neoplastic tissue to RNA and DNA.
• Maintain a database containing banking information, histologic diagnoses, information on derived specimens (RNA/DNA) and images of H&E histology of banked tissue
• Release tissues at the request of the DCI disease-specific working groups either as de-identified tissue or with a link to the patient identity (tissue release linked to PHI requires separate IRB review and approval for your specific project).
• Tissue processing (to RNA and DNA) to individual investigators on a fee for service basis

For Additional Information

The BRPC would be happy to provide additional information. If you would like a complete copy of our research protocol, to see if it would meet your needs, please contact the BRPC Staff or call 919.684.6928.

A list of the DCI disease-specific Working Group Directors is provided for reference below: