BIOREPOSITORY AND TISSUE PROCESSING CORE FACILITY
Director:
Joseph E. Willis, MD
Associate Professor, Pathology
joseph.willis@case.edu
Services
Procurement and Distribution | Types of Tissue Available |
Requirements for Distribution | Data and Links to Patient Information
Procurement and Distribution
The Case Comprehensive Cancer Center's Biorepository and Tissue Processing Core Facility (BTPC) serves two primary functions:
- To build an inventory of remnant human tissues, blood and other body fluids (collectively termed biospecimens) targeted towards cancer and other medical research, for later assignment to investigators;
- To provide long term, controlled storage of biospecimens for specific researchers.
These samples are for research purposes only and may not be used for clinical diagnosis or implantation into humans. Clinical information relating to the samples and donors are collected and maintained in a secure database. Samples and data are de-identified or de-linked before release to the researcher unless he/she has specific IRB approval to gain access to this information.
Remnant biospecimens are prospectively collected from surgical procedures, autopsies and clinical laboratories for the BTPC by the Human Tissue Procurement Facility (HTPF), which operates under UH-IRB Protocol 01-02-45. Blood and bone marrow specimens are collected for the BTPC by the Hematopoietic Stem Cell Core Facility (HSCC), which operates under UH-IRB Protocol 09-90-195.
The Division of Surgical Pathology at University Hospitals Case Medical Center (UHCMC) has clinical archives of paraffin blocks that can be made available through the BTPC for retrospective research studies under the approval of the Vice Chair for Clinical Affairs at UHCMC. Surgical Pathologists associated with the BTPC are responsible for determining which blocks can be made available and how much material can be removed from the blocks.
Biospecimens and associated demographic and histopathologic data are distributed to researchers following a review and approval process described in the Requirement for Distribution Section.
Types of Tissue Available
- Malignant, benign, diseased, normal and normal human tissues
- Normal adjacent tissues available paired with tumor specimens in many cases
- Tissues are collected from over 50 anatomic sites
- Frozen specimens, OCT-embedded and paraffin-embedded tissues
- Large array of paraffin-embedded specimens from clinical archives of paraffin blocks and QC research blocks maintained by the HTPF
- Peripheral blood and bone marrow samples from initial visits and follow-up procedures are processed to obtain serum and cell fractions for storage
- No samples are collected from individuals with known infectious illnesses
- Fetal biospecimens are not collected due to state and local statutes
Requirements for Distribution
BTPC Application
In order to receive biospecimens and data from the BTPC, researchers must complete an application and provide a copy of their current IRB approval to conduct the work.
IRB Approval
Research using human biospecimens from living individuals is considered human subjects research in accordance with the policies of the U.S. Office of Human Research Protections (OHRP). An expedited or full board IRB approval is normally required to obtain tissues from the BTPC for a study. Research involving the use of anonymous or anonymized (de-linked) specimens generally does not qualify as human subject research, but the IRB must be contacted to obtain verification in writing that the project does not require IRB review.
Data Use Agreement
The BTPC requires Data Use Agreements from investigators to release any de-identified data or Limited Data Sets.
Review Committee Approval/Priority
The BTPC review committee or designee reviews and approves BTPC applications. Priority of access to BTPC resources is determined during the review process, taking into consideration the Comprehensive Cancer Center's focus areas and initiatives. Cancer Center members have highest priority access to the biorepository but other on-campus and off-campus researchers may have access to BTPC resources.
Transfer of Materials to Collaborators
Biospecimens provided to investigators for research, and derivatives thereof, may be transferred along with associated de-identified pathology reports by the researcher to collaborators for further study, provided that the following conditions are met:
- An explanation of the need to transfer the materials and benefit to the researcher's study is reviewed and approved by the Director of the BTPC;
- A copy of the Agreement Page from the BTPC Application is signed both by the collaborator and authorized Agency Official and forwarded to the BTPC for approval; and
- A copy of the collaborator's IRB approval to use the biospecimens or their derivatives in research is provided to the BTPC, unless the collaborator is covered under the IRB approval granted for the project in the researcher's application.
External Academic and Commercial Users
Biospecimens stored by the BTPC that are found not to be needed for in-house research may be provided to external academic and commercial researchers for research and development projects. Each researcher is required to obtain his/her local IRB approval for the study. In addition, the BTPC Advisory Board must approve each researcher's formal application to the BTPC. No biospecimens are provided by the BTPC for direct incorporation or further processing into commercial products.
Data and Links to Patient Information
Standard Data
Patient confidentiality is strictly maintained through the use of sample code numbers. Researchers are provided with requested biospecimens and corresponding coded Surgical Pathology or Autopsy Reports. Standard information that is made available includes patient age, race, gender, final diagnosis, and sample type and weight. The samples and data are either be de-identified or de-linked as appropriate before release to the investigator.
Additional Data Available
Chart reviews can be performed to obtain additional clinical information associated with the biospecimens. These data are provided to the investigator in de-identified manner unless the researcher has specific IRB approval to gain access to the patients' identities and medical records. De-linked specimens are not traceable, and as such no further information can be obtained for these samples.
Instructions to Investigators and Links to Forms
Details to follow
Contact for Information
| Locations: | Wearn Building, Rm. 333 (Tissue Procurement) |
|---|---|
| and Institute of Pathology, Rm. B-11 (Histology) | |
| Director: | Joseph Willis, MD |
| Phone: | 216/844-8292 |
| E-mail: | joseph.willis@case.edu |