title: The development of common data elements for a multi-institute prostate cancer tissue bank: the Cooperative Prostate Cancer Tissue Resource (CPCTR) experience.
abstract: BACKGROUND
  The Cooperative Prostate Cancer Tissue Resource (CPCTR) is a consortium of four geographically dispersed institutions that are funded by the U.S. National Cancer Institute (NCI) to provide clinically annotated prostate cancer tissue samples to researchers. To facilitate this effort, it was critical to arrive at agreed upon common data elements (CDEs) that could be used to collect demographic, pathologic, treatment and clinical outcome data.
  
  
  METHODS
  The CPCTR investigators convened a CDE curation subcommittee to develop and implement CDEs for the annotation of collected prostate tissues. The draft CDEs were refined and progressively annotated to make them ISO 11179 compliant. The CDEs were implemented in the CPCTR database and tested using software query tools developed by the investigators.
  
  
  RESULTS
  By collaborative consensus the CPCTR CDE subcommittee developed 145 data elements to annotate the tissue samples collected. These included for each case: 1) demographic data, 2) clinical history, 3) pathology specimen level elements to describe the staging, grading and other characteristics of individual surgical pathology cases, 4) tissue block level annotation critical to managing a virtual inventory of cases and facilitating case selection, and 5) clinical outcome data including treatment, recurrence and vital status. These elements have been used successfully to respond to over 60 requests by end-users for tissue, including paraffin blocks from cases with 5 to 10 years of follow up, tissue microarrays (TMAs), as well as frozen tissue collected prospectively for genomic profiling and genetic studies. The CPCTR CDEs have been fully implemented in two major tissue banks and have been shared with dozens of other tissue banking efforts.
  
  
  CONCLUSIONS
  The freely available CDEs developed by the CPCTR are robust, based on "best practices" for tissue resources, and are ISO 11179 compliant. The process for CDE development described in this manuscript provides a framework model for other organ sites and has been used as a model for breast and melanoma tissue banking efforts.
authors.affiliation: Department of Pathology, Center for Pathology Informatics, Benedum Oncology Informatics Center, University of Pittsburgh, Pittsburgh, PA, USA. patelaa@upmc.edu
authors.forename: Ashokkumar A
authors.initials: AA
authors.lastname: Patel
authors.forename: André
authors.initials: A
authors.lastname: Kajdacsy-Balla
authors.forename: Jules J
authors.initials: JJ
authors.lastname: Berman
authors.forename: Maarten
authors.initials: M
authors.lastname: Bosland
authors.forename: Milton W
authors.initials: MW
authors.lastname: Datta
authors.forename: Rajiv
authors.initials: R
authors.lastname: Dhir
authors.forename: John
authors.initials: J
authors.lastname: Gilbertson
authors.forename: Jonathan
authors.initials: J
authors.lastname: Melamed
authors.forename: Jan
authors.initials: J
authors.lastname: Orenstein
authors.forename: Kuei-Fang
authors.initials: KF
authors.lastname: Tai
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Becich
mesh_terms: D019295:Computational Biology / Q000379:methods*; D003201:Computers; D019992:Databases as Topic; D006801:Humans; D008297:Male; D011471:Prostatic Neoplasms / Q000378:metabolism / Q000473:pathology*; D012008:Recurrence; D012984:Software; D014015:Tissue Banks; D016896:Treatment Outcome