The response to our concept of an international bladder cancer data and tissue bank has been extremely encouraging. Investigators at the AACR, EAU and the AUA expressed a lot of interest in participation and their input has been very helpful. It became obvious during those discussions, that there is a need to propose a specific project, as well as further develop the details of the data and tumor bank aspects.
The following is a brief summary of topics discussed and ideas proposed.

Infrastructure

      Database and Tumor Bank

• There is a need to standardize the procedures of tumor and data acquisition for this international data and tissue bank.
• Tumor banks and procedures are in place in many institutions, and there are several important existing networks and collaborations with an estimated overall number of more than 2000 samples available for this project.
• A first step should be review and try to accommodate the procedures of data and tissue collection that are already in place. Each institution willing to participate should therefore provide a detailed "protocol" of the tissue and data procurement performed at the institution.The  "Tissue/Methodology group" (see below) should review the different procedures and develop general policies as well as specific standards to be used by all participants of the international bladder cancer bank.

        Action groups

To share the workload and also to focus on the different aspects of this project, the organization of different "action groups" became obvious. Currently four groups are proposed.

I. Data base / Statistics

• Quality assurance
• Internet security
• Study design
• Analysis of results


II. Tissue / Methodology

• Use of existing sources / integration of existing databases
• Storage and transfer of specimens (if needed for specific projects)
• Estimate the cost of sample acquisition
• Pilot-studies for evaluation of protocols


III. Translational / protocol

• Evaluate mechanisms to review protocols (external committee ?)
• Ethic considerations like patient confidentiality or informed consents
• Develop study protocol for initial study (see below)


IV. Core group

• Provide guidelines for this project with regards to
  - publication/authorship
  - Discovery protection
• Decision on server location and core facilities
• Qualification of membership

There was consensus that in order to launch the bank, we should begin with a specific project. We are currently thinking of a tissue-array study.
This study should:
• Serve for the validation of the method and the different protocols for marker evaluation
• Include important "markers" for G1-S transition and might focus on molecular targets involved in the G2-M transition
• Serve as backbone for the infrastructure and methodological issues of the "bank"

Funding

Obtaining funding remains an important first step. To split the project to obtain two-sided funding, one American (including Canada) and one European was discussed as well as to implement different sources in the project.

• NCI or NIH funded international collaborations
• EORTC supported funding
• Funding for network establishment through the European Community
• Small business funding for software development
• Technology transfer grants for the Tissue arrayer project

Next Meeting

The next meeting where this project will be discussed including these updated thoughts will be at the NCI-EORTC meeting held in Nyborg, Denmark 29th June-1st July 2000. The program is available on the following web page: http://www.cdp.ims.nci.nih.gov/eortc/program.html

Yours sincerely,
 

Peter J. Goebell, MD USC/Hoffman Medical Research Center Departments of Urology and Pathology 2011 Zonal Avenue, Room 308 Los Angeles, CA 90033 Tel: 323-442-1152 Fax: 323-442-1154 goebell@usc.edu

Susan G. Groshen, PhD USC/Norris Cancer Center Department of Preventive Medicine 1441 Eastlake Avenue, Suite 3419 Los Angeles, CA 90089 Tel: 323-865-0375 Fax: 323-865-0133   groshen@usc.edu