Biosample Repository Facility

	Denise Connolly, PhD Facility Director [email protected]
	Hong Wu, MD, PhD Pathology Consultant [email protected]
	Brittaney L. Brown, BA Facility Manager [email protected]

Donor recruitment, biospecimen collection and processing

	Traci Brown Research Patient Recruiter [email protected]
	Barbara D. Dettore, BSW Research Study Assistant [email protected]
	Mary Donovan, CTR Senior Data Manager [email protected]
	Diane Faison Scientific Technician II [email protected]
	Mary Pat Gilroy, AS Research Study Assistant [email protected]
	Alexis Koemm, BS Scientific Technician II [email protected]

Tissue collection, TMA construction, immunohistochemistry and automated image analysis

	James Hittle Technical Specialist [email protected]
	Karen Kaputa, MLT/HLT, ASCP Staff Tech/Tumor Bank Manager [email protected]
	Chao Wu, MS Technical Specialist [email protected]

Guidelines

The Biosample Repository Facility (BRF) staff consents patients for the collection of biospecimens including blood, urine, saliva, bone marrow and tissue. The Facility also consents people without known cancer for donation of blood. Patients coming to FCCC for pre-surgical evaluation or non-surgical appointments are contacted by telephone or approached by BRF patient recruiters for consent in Pre-Admission Testing (PAT) or at clinic visits. Each patient is asked to read and sign two documents: 1) Informed Consent Document and 2) Authorization (Permission) to Use or Disclose (Release) Protected Health Information (PHI) for Research. Participants are also asked to complete a health history questionnaire. The potential risks and benefits of participation are fully explained and discussed with each potential participant through a process of informed consent. Participants are given multiple opportunities to ask questions and may withdraw from the study at any time. Collection of biospecimens and associated data for the BRF is approved by the Fox Chase Cancer Center (FCCC) Institutional Review Board (IRB). All key personnel involved in the design or conduct of the research involving human tissues have received the required education on the protection of human research participants.

Due to the sensitive nature of family and personal medical information, the BRF takes precautions to protect the privacy of participants. Each participant is given a unique participant identification code number that is associated with all demographic, questionnaire data and biospecimens. In addition, all biospecimens are assigned specimen-specific identification numbers at the time of collection. Each sample barcode and number is printed on the label in a legible form and all references to the participant's name and address are removed. The information collected is handled according to the strict guidelines of a monitored research environment and does not become part of a permanent medical record nor is it made available to other individuals or institutions. Access to confidential information, such as names and addresses and other personal health information are limited to the staff of the BRF and Population Studies Facility (PSF). The FCCC computers used for storing the information are protected from inappropriate outside access by the FCCC firewall provided by the Research Computing Services Internet Working Facility at FCCC. All BRF personnel are instructed in the ethics of data access.

BRF Oversight and Review of Requests for Specimens and Data

Operation of the Biosample Repository is the responsibility of Dr. Denise Connolly who provides overall direction and supervision of the Facility manager and individuals in charge of collecting, processing and distributing the biospecimens and the epidemiologic data donated by eligible research participants. Dr. Hong Wu, a Board Certified Anatomic Pathologist, reviews all tumor tissues that are deposited in the BRF. The BRF has a Faculty Advisory Committee (FAC) comprised of faculty members including Pathologists, Medical Oncologists, Basic Scientists and Behavioral Scientists that is directly involved in the development of BRF policies and procedures to accommodate the unique resources and needs of individual investigators. The FAC meets formally with Dr. Connolly annually to review all issues related to the BRF and provide advice for new policies and procedures proposed for the BRF. The BRF FAC provides an annual summary report to the Facilities Parental Oversight Committee that in turn reports to Dr. Jonathan Chernoff, the Chief Scientific Officer.

The BRF makes specimens and services available to FCCC investigators and external users. Investigators interested in using the BRF resources are asked to submit Specimen Request Form for review of investigator requests for BRF biospecimens. Investigators are required to submit a detailed research proposal, which is reviewed by the Facility Director and Manager to ensure feasibility and availability of the requested materials, and must be approved by the Institutional Review Board (IRB). Specimen requests for limited availability specimens are reviewed by members of the BRF FAC. These independent methods of review help to optimize use of this precious resource. Priority is given to investigators who have received peer-reviewed grant support. External investigators will have access to the biospecimens once the IRB (at the requesting institute) and the BRF and FAC have granted approval of the proposed studies. Once requests are approved, the BRF staff assembles the requested materials and ships to the requesting investigator. Pre-surgical serum/plasma and primary tumor samples are the most commonly depleted resource. In such cases, the following guidelines are followed:

• Priority 1 - NCI/NIH funded FCCC investigators
• Priority 2 - Other funded FCCC investigators
• Priority 3 - Non-funded FCCC investigators (primarily junior investigators)
• Priority 4 - NCI/NIH funded investigators outside of FCCC
• Priority 5 - Other funded investigators outside of FCCC
• Priority 6 - Non-funded Investigators outside of FCCC

Available Specimens

View Inventory Lists

To request specimens, please follow the link for the specimen request form, complete and return to Brittaney Brown, BRF manager, at [email protected] or [email protected]. Please feel free to call us at 215-214-1633 with any questions.

BRF Specimen Request Form — Internal (FCCC/TUHS staff only)

BRF Specimen Request Form — External

Progress cancer research has increased tremendously due to experiments preformed in laboratories on samples obtained from patients with and without cancer. Laboratory-based studies of human specimens help scientists discover the cause of a cancer by identifying abnormalities present in cancer cells and in the surrounding cells in their environment. These discoveries have the potential to lead to new ways to detect and treat cancer. To facilitate these new discoveries, Fox Chase Cancer Center established a centralized Biosample Repository designed to collect biospecimens, including tumor tissue and bodily fluids, including blood, urine, and saliva from patients who have cancer, and blood and saliva from participants without cancer, to support scientific research in laboratories to learn more about cancers. Participation in the Biosample Repository is voluntary and includes only people who choose to take part.

If you choose to participate in the Biosample Repository, you may be asked to donate blood, excess tumor tissue that is removed and would otherwise be discarded, and in some cases, additional blood or urine samples annually or on return visits for follow-up care. In addition, we will ask you to fill out a questionnaire to provide your health information. The Biosample Repository may also collect medical information about you and your samples from your medical record. To protect your privacy, each participant will be given a code number for use in the Biosample Repository. The coded samples and your data will then be stored in the Biosample Repository Facility.

Contact Information

Denise C. Connolly, PhD
Director, Biosample Repository Facility
[email protected]

Brittaney L. Brown, BA
Manager, Biosample Repository Facility
[email protected]
215-214-1633