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Experimental Design

Tissue

Each participating institution will provide 30 formalin-fixed, paraffin-embedded tumor blocks of pT3 TCC. Twenty-five of these should be node negative (at least one node examined) and five should be node positive (positive and negative nodes documented). These blocks will be combined into a single tissue microarray containing approximately 600 different tumors. Additional cores will be included in the array from 10 normal bladders, from 30 non-bladder tissues (positive and negative controls) and from 10 cell lines having known antigen status.

Cores will be taken from each block for inclusion in the array. Areas for sampling of each core will be identified from an H&E section from the surface of each block (10 thin sections will be taken from each block for control stains). Each core will be 0.6 mm in diameter. Ten cores will be taken from each block. Six cores will be used for six identical arrays, and the remaining four cores will be used for DNA extraction.

All blocks will be returned to the originating institution after the arrays are produced. It is expected that each array block will yield ~200 sections, each containing the full set of tumor and control cores. Sections from these blocks will be distributed to the participating institutions for further studies.

Institutional Review Board Approvals

Each participating institution will be required to receive approval from their Institutional Review Board on Human Experimentation before submitting archival blocks to the Consortium. It should be made clear to the local IRB that each sample will be coded at the originating institution and only this coded identity will be used by any of the other participants. Thus confidentiality of the patient identify will be entirely protected behind a firewall at each institution.

In addition, any institution requesting sections for study must all have approval (or certification of exemption). Please ensure that you have IRB approval. Send verification of IRB approval to:

Elsa M. Perezous, Grant Administrator
Genitourinary SPORE Program
The University of Texas MD Anderson Cancer Center
Genitourinary Program Center - Unit 1372
1515 Holcombe Blvd.
Houston, Texas 77030
Phone: 713-563-5957, FAX: 713-792-6099
E-mail: eperezou@mdanderson.org

Clinical Data

Each institution will provide a defined set of data associated with each tumor specimen. The identification of block and corresponding data will be coded to protect confidentiality. No patient identifying information will be used. A central biostatistical core will be responsible for reviewing the data for completeness, assessing quality of data (entry consistency, etc.), organizing the information and performing the statistical analyses of the results. The Data Collection Form summarizes the minimum data requested.

Instructions

  • Provide blocks collected before 2001, and send blocks along with patient data.
  • Include patient identifier number and specimen identification number.
  • Submit electronic version to:

In USA or Canada:
Frederic M. Waldman, M.D., Ph.D.
Professor, Laboratory Medicine and Urology, UCSF.
2340 Sutter St., S-436
San Francisco 94115
415-476-3821 (voice)
415-476-8218 (fax)
E-mail: waldman@cc.ucsf.edu

In Europe:
Dr. Peter J. Goebell, M.D.
Department of Urology
University Clinic Essen
Hufelandstrasse 55D-45122
Essen, Germany
Telephone: +49 (0)201-723 3221
Fax: +49 (0)201-723 5902
E-mail: peter.goebell@uni-essen.de

  • Study Results
  • Information for MD Anderson Network Users

© 2014 The University of Texas MD Anderson Cancer Center